journey medical accutane

Fortress Biotech, Inc.

Press releases, fortress biotech’s partner company, journey medical corporation, in-licenses and launches accutane® for the treatment of severe recalcitrant nodular acne, accutane is journey medical’s sixth marketed dermatology product.

NEW YORK and SCOTTSDALE, Ariz., March 22, 2021 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), today announced that Journey Medical Corporation (“Journey Medical”), a partner company of Fortress, in-licensed and launched an oral isotretinoin under the brand name Accutane ® (isotretinoin capsules USP) in the U.S. Accutane is an oral medication that is indicated for the treatment of severe recalcitrant nodular acne. It is only available by prescription at major U.S. retail and specialty pharmacy chains.

Claude Maraoui, President and Chief Executive Officer of Journey Medical, stated, “We are proud to add Accutane to our growing portfolio of dermatology products, which also includes Targadox ® (doxycycline hyclate tablets USP) and Ximino ® (minocycline hydrochloride extended-release capsules). Licensing and launching Accutane allows us to leverage the strength of its brand name with our experienced acne sales team. We are poised for an exciting year as we launch this brand under the Journey Medical umbrella.”

Acne is one of the most commonly treated disease states in dermatology. Acne is most common among teenagers, though it affects people of all ages. Accutane belongs to a class of drugs that may affect all four major pathogenic processes in acne: increased sebum production, irregular follicular desquamation, propionibacterium acnes proliferation and inflammation. Over 1.8 million prescriptions were written for all isotretinoin products in 2020, according to Symphony Health.

Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer of Fortress, added, “The in-licensing of Accutane and expansion of Journey Medical’s portfolio of branded dermatology products showcases Fortress’ unique business model designed to acquire and rapidly advance overlooked yet potentially transformative assets to patients. We are excited about the growth potential that this newly acquired product will bring to our revenue-generating partner company.”

For full prescribing information about Accutane, please visit www.rxaccutane.com .

IMPORTANT SAFETY INFORMATION FOR ACCUTANE® (ISOTRETINOIN)

Important Safety Information for Accutane® (isotretinoin) What is the most important information I should know about Accutane? Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Accutane. Patients must not get pregnant:

• for 1 month before starting Accutane
• while taking Accutane
• for 1 month after stopping Accutane

If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider. Accutane is only for patients who can understand and agree to follow all the instructions in the iPLEDGE ® Program. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com . See your healthcare provider for further information. Accutane can cause serious mental health problems, including:

• psychosis (seeing or hearing things that are not real)
• suicide . Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.

Stop Accutane and call your healthcare provider right away if you or a family member notices that you have any signs and symptoms of depression or psychosis:

• start to feel sad or have crying spells
• lose interest in activities you once enjoyed
• sleep too much or have trouble sleeping
• become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
• have a change in your appetite or body weight
• have trouble concentrating
• withdraw from your friends or family
• feel like you have no energy
• have feelings of worthlessness or guilt
• start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
• start acting on dangerous impulses
• start seeing or hearing things that are not real

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

Who should not take Accutane? 

• Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment.  Accutane causes severe birth defects. See  “What is the most important information I should know about Accutane?” 
• Do not take Accutane if you are allergic to anything in it.  See the end of this Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives.

What should I tell my doctor before taking Accutane?  Tell your doctor if you or a family member has any of the following health conditions: 

• mental problems
• liver disease
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little)
• food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding. Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.  Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

• Vitamin A supplements.  Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics.  Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
• Progestin-only birth control pills (mini-pills).  They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin).  This medicine taken with Accutane may weaken your bones.
• Corticosteroid medicines.  These medicines taken with Accutane may weaken your bones.
• St. John’s Wort.  This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with Accutane unless your doctor tells you it is okay.  Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

What should I avoid while taking Accutane? 

• Do not get pregnant  while taking Accutane and for one month after stopping Accutane. See  “What is the most important information I should know about Accutane?” 
• Do not breast feed  while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
• Do not give blood  while you take Accutane and for one month after stopping Accutane. If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products  with Accutane unless you talk to your doctor. See  “What should I tell my doctor before taking Accutane?” 
• Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop.  Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights  as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
• Do not share Accutane with other people.  It can cause birth defects and other serious health problems.

What are the possible side effects of Accutane?

• Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
• Accutane can cause serious mental health problems.
• bad headache
• blurred vision
• nausea or vomiting
• seizures (convulsions)
• conjunctivitis (red or inflamed eyes, like “pink eye”)
• rash with a fever
• blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes
• skin begins to peel
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• rectal bleeding
• yellowing of your skin or eyes
• Bone or muscle problems. Accutane may affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones. Stop Accutane and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Accutane may stop long bone growth in teenagers who are still growing.
• Hearing problems. Stop using Accutane and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• Vision problems. Accutane may affect your ability to see in the dark. Stop taking Accutane and call your healthcare provider right away if you have problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Accutane.
• Lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. These problems usually go away when Accutane treatment is finished.
• Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
• Blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.
• Decreased red or white blood cells. Call your healthcare professional if you have trouble breathing, faint, or feel weak.

The common, less serious side effects of Accutane include:

• Chapped lips
• Dry nose that may lead to nosebleeds

These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at 1-844-325-3350.

About Journey Medical Corporation Journey Medical Corporation (“Journey Medical”) is focused on identifying, acquiring and strategically commercializing innovative, differentiated dermatology products through its efficient sales and marketing model. The company currently markets six products that help treat and heal common skin conditions. The Journey Medical team is comprised of industry experts with extensive experience commercializing some of the most successful prescription dermatology brands. Journey Medical is located in Scottsdale, Arizona and is a partner company of Fortress Biotech, Inc. (NASDAQ:FBIO). Accutane is being launched by JG Pharma, Inc., a wholly owned subsidiary of Journey Medical. For additional information about Journey Medical, visit www.journeymedicalcorp.com.

About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage pharmaceutical products and product candidates. The company has six marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com .

Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; risks pertaining to bodily injury or death from Accutane and/or isotretinoin products (and resultant litigation); government regulation; patent and intellectual property matters; competition; as well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contacts: Jaclyn Jaffe and William Begien Fortress Biotech, Inc. (781) 652-4500 [email protected]

Investor Relations Contact: Daniel Ferry LifeSci Advisors, LLC (617) 430-7576 [email protected]

Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 [email protected]   

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d2ab8b95-29cc-46e9-a41c-851575f07e64

IMPORTANT SAFETY INFORMATION

CAUSES BIRTH DEFECTS - DO NOT GET PREGNANT

Released March 22, 2021

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Journey Medical Corporation Launches Accutane for the Treatment of Severe Recalcitrant Nodular Acne

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Accutane is Journey Medical’s sixth marketed dermatology product Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), today announced that Journey Medical Corporation (“Journey Medical”), a partner company of Fortress, in-licensed and launched oral isotretinoin under the brand name Accutane® (isotretinoin capsules USP) in the U.S. Accutane is an oral medication that is indicated for the treatment of severe recalcitrant nodular acne. It is only available by prescription at major U.S. retail and specialty pharmacy chains. Claude Maraoui, President and Chief Executive Officer of Journey Medical, stated, “We are proud to add Accutane to our growing portfolio of dermatology products, which also includes Targadox® (doxycycline Hyclate tablets USP) and Ximino® (minocycline hydrochloride extended-release capsules). Licensing and launching Accutane allows us to leverage the strength of its brand name with our experienced acne sales team. We are poised for an exciting year as we launch this brand under the Journey Medical umbrella.” Acne is one of the most commonly treated disease states in dermatology. Acne is most common among teenagers, though it affects people of all ages. Accutane belongs to a class of drugs that may affect all four major pathogenic processes in acne: increased sebum production, irregular follicular desquamation, propionibacterium acnes proliferation, and inflammation. Over 1.8 million prescriptions were written for all isotretinoin products in 2020, according to Symphony Health. Lindsay A. Rosenwald, M.D., Chairman, President, and Chief Executive Officer of Fortress, added, “The in-licensing of Accutane and expansion of Journey Medical’s portfolio of branded dermatology products showcases Fortress’s unique business model designed to acquire and rapidly advance overlooked yet potentially transformative assets to patients. We are excited about the growth potential that this newly acquired product will bring to our revenue-generating partner company.” For full prescribing information about Accutane, please visit www.rxaccutane.com.

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Fortress biotech’s partner company, journey medical corporation, in-licenses and launches accutane® for the treatment of severe recalcitrant nodular acne.

Accutane is Journey Medical’s sixth marketed dermatology product

IMPORTANT SAFETY INFORMATION

Causes birth defects - do not get pregnant.

NEW YORK and SCOTTSDALE, Ariz., March 22, 2021 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), today announced that Journey Medical Corporation (“Journey Medical”), a partner company of Fortress, in-licensed and launched an oral isotretinoin under the brand name Accutane ® (isotretinoin capsules USP) in the U.S. Accutane is an oral medication that is indicated for the treatment of severe recalcitrant nodular acne. It is only available by prescription at major U.S. retail and specialty pharmacy chains.

Claude Maraoui, President and Chief Executive Officer of Journey Medical, stated, “We are proud to add Accutane to our growing portfolio of dermatology products, which also includes Targadox ® (doxycycline hyclate tablets USP) and Ximino ® (minocycline hydrochloride extended-release capsules). Licensing and launching Accutane allows us to leverage the strength of its brand name with our experienced acne sales team. We are poised for an exciting year as we launch this brand under the Journey Medical umbrella.”

Acne is one of the most commonly treated disease states in dermatology. Acne is most common among teenagers, though it affects people of all ages. Accutane belongs to a class of drugs that may affect all four major pathogenic processes in acne: increased sebum production, irregular follicular desquamation, propionibacterium acnes proliferation and inflammation. Over 1.8 million prescriptions were written for all isotretinoin products in 2020, according to Symphony Health.

Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer of Fortress, added, “The in-licensing of Accutane and expansion of Journey Medical’s portfolio of branded dermatology products showcases Fortress’ unique business model designed to acquire and rapidly advance overlooked yet potentially transformative assets to patients. We are excited about the growth potential that this newly acquired product will bring to our revenue-generating partner company.”

For full prescribing information about Accutane, please visit www.rxaccutane.com .

IMPORTANT SAFETY INFORMATION FOR ACCUTANE® (ISOTRETINOIN)

Important Safety Information for Accutane® (isotretinoin) What is the most important information I should know about Accutane? Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Accutane. Patients must not get pregnant:

for 1 month before starting Accutane

while taking Accutane

for 1 month after stopping Accutane

If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider. Accutane is only for patients who can understand and agree to follow all the instructions in the iPLEDGE ® Program. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com . See your healthcare provider for further information. Accutane can cause serious mental health problems, including:

psychosis (seeing or hearing things that are not real)

suicide . Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.

Stop Accutane and call your healthcare provider right away if you or a family member notices that you have any signs and symptoms of depression or psychosis:

start to feel sad or have crying spells

lose interest in activities you once enjoyed

sleep too much or have trouble sleeping

become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)

have a change in your appetite or body weight

have trouble concentrating

withdraw from your friends or family

feel like you have no energy

have feelings of worthlessness or guilt

start having thoughts about hurting yourself or taking your own life (suicidal thoughts)

start acting on dangerous impulses

start seeing or hearing things that are not real

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

Who should not take Accutane?

Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See “What is the most important information I should know about Accutane?”

Do not take Accutane if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives.

What should I tell my doctor before taking Accutane? Tell your doctor if you or a family member has any of the following health conditions:

mental problems

liver disease

heart disease

bone loss (osteoporosis) or weak bones

an eating problem called anorexia nervosa (where people eat too little)

food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding. Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.

Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.

Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.

Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.

Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.

St. John’s Wort. This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with Accutane unless your doctor tells you it is okay. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

What should I avoid while taking Accutane?

Do not get pregnant while taking Accutane and for one month after stopping Accutane. See “What is the most important information I should know about Accutane?”

Do not breast feed while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.

Do not give blood while you take Accutane and for one month after stopping Accutane. If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects.

Do not take other medicines or herbal products with Accutane unless you talk to your doctor. See “What should I tell my doctor before taking Accutane?”

Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.

Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.

Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.

Do not share Accutane with other people. It can cause birth defects and other serious health problems.

What are the possible side effects of Accutane?

Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.

Accutane can cause serious mental health problems.

Serious brain problems . Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your healthcare provider right away if you get any of these signs of increased brain pressure:

bad headache

blurred vision

nausea or vomiting

seizures (convulsions)

Skin problems. Skin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your healthcare provider immediately if you develop:

conjunctivitis (red or inflamed eyes, like “pink eye”)

rash with a fever

blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes

skin begins to peel

Stomach area (abdomen) problems. Certain symptoms may mean your internal organs are being damaged, such as the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop Accutane and call your healthcare provider if you get:

severe stomach, chest or bowel pain

trouble swallowing or painful swallowing

new or worsening heartburn

rectal bleeding

yellowing of your skin or eyes

Bone or muscle problems. Accutane may affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones. Stop Accutane and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Accutane may stop long bone growth in teenagers who are still growing.

Hearing problems. Stop using Accutane and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.

Vision problems. Accutane may affect your ability to see in the dark. Stop taking Accutane and call your healthcare provider right away if you have problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Accutane.

Lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. These problems usually go away when Accutane treatment is finished.

Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.

Blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.

Decreased red or white blood cells. Call your healthcare professional if you have trouble breathing, faint, or feel weak.

The common, less serious side effects of Accutane include:

Chapped lips

Dry nose that may lead to nosebleeds

These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at 1-844-325-3350.

About Journey Medical Corporation Journey Medical Corporation (“Journey Medical”) is focused on identifying, acquiring and strategically commercializing innovative, differentiated dermatology products through its efficient sales and marketing model. The company currently markets six products that help treat and heal common skin conditions. The Journey Medical team is comprised of industry experts with extensive experience commercializing some of the most successful prescription dermatology brands. Journey Medical is located in Scottsdale, Arizona and is a partner company of Fortress Biotech, Inc. (NASDAQ: FBIO ). Accutane is being launched by JG Pharma, Inc., a wholly owned subsidiary of Journey Medical. For additional information about Journey Medical, visit www.journeymedicalcorp.com.

About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage pharmaceutical products and product candidates. The company has six marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com .

Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; risks pertaining to bodily injury or death from Accutane and/or isotretinoin products (and resultant litigation); government regulation; patent and intellectual property matters; competition; as well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contacts: Jaclyn Jaffe and William Begien Fortress Biotech, Inc. (781) 652-4500 [email protected]

Investor Relations Contact: Daniel Ferry LifeSci Advisors, LLC (617) 430-7576 [email protected]

Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 [email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d2ab8b95-29cc-46e9-a41c-851575f07e64

Press Releases

Journey medical corporation reports first quarter 2024 financial results and recent corporate highlights, related documents.

New Drug Application for DFD-29 to treat rosacea accepted for U.S. FDA review; PDUFA goal date of November 4, 2024

Total revenues for the first quarter ended March 31, 2024 were $13.0 million, a 7% increase from the $12.2 million reported in the first quarter of 2023

Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update

SCOTTSDALE, Ariz., May 13, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2024.

Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “We delivered solid first quarter results with year-over-year revenue growth of 7%. These results were driven by greater than 20% year-over-year growth in our flagship products, Qbrexza® and Accutane®.”

Mr. Maraoui continued, “Additionally, we made significant progress advancing our development program for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg). Following our positive Phase 3 clinical trial results, the FDA accepted our New Drug Application (“NDA”) in March 2024, and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024. We believe this is a pivotal milestone for Journey Medical, as DFD-29, if approved, represents a significant commercial opportunity for the Company. We remain focused on driving growth and profitability from our current dermatology franchise and look forward to the opportunity to launch DFD-29 to benefit patients with rosacea and to leverage our existing commercial infrastructure.”

Financial Results:

• Total net product revenues were $13.0 million for the first quarter of 2024, representing 7% growth compared to net product revenues of $12.2 million for the first quarter of 2023. The increase is primarily due to an increase in net product revenues for Qbrexza and Accutane as the Company continues to focus marketing efforts on these products. The increase was partially offset by a decrease in net product revenues from Amzeeq® and Zilxi® as a result of lower sales volume and Targadox® and Ximino®. Targadox continues to experience erosion due to generic competition and the Company discontinued selling Ximino at the end of the third quarter 2023.
• Cost of goods sold increased by $0.4 million to $6.8 million for the three-month period ended March 31, 2024, from $6.4 million for the three-month period ended March 31, 2023, due to the increase in net product revenues.
• Research and development costs were $7.9 million in the first quarter of 2024, compared to $2.0 million in the first quarter of 2023. The increase is driven by a $4.0 million filing fee payment to the FDA in January 2024 for DFD-29 in addition to an accrued $3.0 million expense, for a contractual milestone payment owed to Dr. Reddy’s Laboratories, Ltd (“DRL”) triggered by the FDA’s acceptance of the DFD-29 NDA submission in March 2024. This was partially offset by lower clinical trial expenses to develop DFD-29 as the project concludes.
• Selling, general and administrative expenses decreased by $4.9 million to $8.4 million for the three-month period ended March 31, 2024, from $13.3 million for the three-month period ended March 31, 2023. The decrease is due to the Company’s expense reduction efforts.
• The Company’s net loss was $10.4 million, or $(0.53) per share basic and diluted, for the first quarter of 2024, compared to a net loss of $10.1 million, or $(0.57) per share basic and diluted, for the first quarter of 2023.
• The Company’s non-GAAP results in the table below reflect Adjusted EBITDA of $11,000, or $0.001 per share basic and diluted, for the first quarter of 2024, compared to Adjusted EBITDA of $(5.3 million), or $(0.30) per share basic and diluted, for the first quarter of 2023. Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are non-GAAP financial measures, each of which are reconciled to the most directly comparable financial measures calculated in accordance with GAAP below under “ Use of Non-GAAP Measures .”
• At March 31, 2024, the Company had $24.1 million in cash and cash equivalents as compared to $27.4 million in cash and cash equivalents at December 31, 2023.

Recent Corporate Highlights:

• In March 2024, the FDA accepted the Company’s NDA filing for DFD-29 and set a PDUFA goal date of November 4, 2024. If approved, DFD-29 has the potential to be the only oral, systemic therapy to address inflammatory lesions and erythema (redness) from rosacea, differentiating it as a potential best-in-class solution for the millions of patients suffering from rosacea. The Company submitted its NDA to the FDA seeking approval for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults in January 2024.

Conference Call and Webcast Information Journey Medical management will conduct a conference call and audio webcast on May 13, 2024, at 4:30 p.m. ET.

To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference here: https://dpregister.com/sreg/10188768/fc6df642e0 . Please note that registered participants will receive their dial-in number upon registration.

A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com , and will remain available for replay for approximately 30 days after the meeting.

About Journey Medical Corporation Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com .

Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful development and regulatory approval of the DFD-29 product candidate and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Company Contact: Jaclyn Jaffe (781) 652-4500 [email protected]

Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 [email protected]   

Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in our Form 10-Q that will be filed with the Securities and Exchange Commission (“SEC”), the Company has, in this press release, included certain non-GAAP measurements, including Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted. We define Adjusted EBITDA as net income (loss) excluding interest, taxes and depreciation, less certain other non-cash and infrequent items not considered to be normal, recurring operating expenses, including, share-based compensation expense, amortization and impairments of acquired intangible assets, severance and foreign exchange transaction losses. In particular, we exclude the following matters for the reasons more fully described below:

• Share-Based Compensation Expense :  We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued.
• Non-core and Short-term Research and Development Expense :  We exclude research and development costs incurred in connection with our DFD-29 product candidate, including the filing fee payment made to the FDA and contractual milestone payment, which is the only product in our portfolio not currently approved for marketing and sale, because we do not consider such costs to be normal, recurring operating expenses that are core to our long-term strategy. Instead, our long-term strategy is focused on the marketing and sale of our core FDA-approved dermatological products and the out licensing our intellectual property and related technologies.
• Amortization and impairments of Acquired Intangible assets :  We exclude the impact of certain amounts recorded in connection with the acquisitions of intangible assets that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization impairments of acquired intangible assets.

Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are determined by dividing the resulting Adjusted EBITDA by the number of shares outstanding on an actual and fully diluted basis.

Management believes the use of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company's results. However, Adjusted EBITDA, Adjusted EBITDA per share basic, Adjusted EBITDA per share diluted and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

The table below provides a reconciliation from GAAP to non-GAAP measures:

Released May 13, 2024

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Not actual pharmacist or patient.

You Could Receive Accutane® for as Little as $0 at a Participating Pharmacy*

Accutane® is exclusively available at in-network pharmacies across the united states.

We are committed to helping as many patients as possible on the journey to healthier skin. Our Journey Total Access Program helps ensure that you receive the medicine your healthcare provider prescribes at an affordable cost.

Pharmacies that carry Accutane® provide additional patient benefits:

• Savings are automatically applied, so you receive the lowest available price*
• Specialists on staff can answer your questions and help with iPLEDGE® REMS compliance to reduce the risk of treatment delays
• The option to ship Accutane® directly to you †

Commercially insured, eligible patients may pay:

*Terms and conditions apply. Not valid for prescriptions reimbursed by Medicare, Medicaid, federal or state programs (including any state prescription drug programs). Offer good only in the United States and cannot be redeemed at government subsidized pharmacies. The selling, purchasing, trading, or counterfeiting of this offer is prohibited by law. Not valid with any other offer. Maximum reimbursement limits apply. Void where prohibited. † Shipping options and costs are dependent on pharmacy offerings.

Find a Pharmacy Near You that Carries Accutane®

All trademarks, logos, and brand names are the property of their respective owners.

Ask Your Dermatologist if Accutane® Could Change your Severe Nodular Acne Story

Are you planning to visit your dermatologist about your reoccurring severe nodular acne? Download the Accutane® Discussion Guide for a list of questions and patient resources.

What is the most important information I should know about Accutane?

Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.

Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Accutane.

Patient must not get pregnant:

• for 1 month before starting Accutane
• while taking Accutane
• for 1 month after stopping Accutane

If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider.

Accutane is only for patients who can understand and agree to follow all the instructions in the iPLEDGE® REMS. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com . See your healthcare provider for further information.

Accutane can cause serious mental health problems, including:

• depression .
• psychosis . (seeing or hearing things that are not real)
• suicide . Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.

Stop Accutane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:

• start to feel sad or have crying spells
• lose interest in activities you once enjoyed
• sleep too much or have trouble sleeping
• become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
• have a change in your appetite or body weight
• have trouble concentrating
• withdraw from your friends or family
• feel like you have no energy
• have feelings of worthlessness or guilt
• start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
• start acting on dangerous impulses
• start seeing or hearing things that are not real

After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.

Who should not take Accutane?

• Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes life-threatening birth defects. See “What is the most important information I should know about Accutane?”
• Do not take Accutane if you are allergic to anything in it. See the end of the Medication Guide for a complete list of ingredients in Accutane.

What should I tell my doctor before taking Accutane?

Tell your doctor if you or a family member has any of the following health conditions:

• mental problems
• liver disease
• heart disease
• bone loss (osteoporosis) or weak bones
• an eating problem called anorexia nervosa (where people eat too little)
• food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
• Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
• Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
• St. John’s Wort. This herbal supplement may make birth control pills work less effectively.

These medicines should not be used with Accutane unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

What should I avoid while taking Accutane?

• Do not get pregnant while taking Accutane and for one month after stopping Accutane. See “What is the most important information I should know about Accutane?”
• Do not breast feed while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
• Do not give blood while you take Accutane and for one month after stopping Accutane. If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane unless you talk to your doctor. See “What should I tell my doctor before taking Accutane?”
• Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
• Do not share Accutane with other people. It can cause birth defects and other serious health problems.

What are the possible side effects of Accutane?

• Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
• Accutane can cause serious mental health problems.
• Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your healthcare provider right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• nausea or vomiting
• seizures (convulsions)
• Skin problems. Skin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your healthcare provider immediately if you develop:
• conjunctivitis (red or inflamed eyes, like “pink eye”)
• rash with a fever
• blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes
• skin begins to peel
• Stomach area (abdomen) problems. Certain symptoms may mean your internal organs are being damaged, such as the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop Accutane and call your healthcare provider if you get:
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• rectal bleeding
• yellowing of your skin or eyes
• Bone or muscle problems. Accutane may affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones. Stop Accutane and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Accutane may stop long bone growth in teenagers who are still growing.
• Hearing problems. Stop using Accutane and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• Vision problems. Accutane may affect your ability to see in the dark. Stop taking Accutane and call your healthcare provider right away if you have problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Accutane.
• Lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Accutane treatment is finished.
• Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
• Blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.
• Decreased red or white blood cells. Call your healthcare professional if you have trouble breathing, faint, or feel weak.

The common, less serious side effects of Accutane include:

• Chapped lips
• Dry nose that may lead to nosebleeds

These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at 1-844-325-3350.

Click here to see the full Prescribing Information for Boxed Warning, Contraindications, other Important Warnings and Precautions, Drug Interactions, Use in Specific Populations, and other Adverse Reactions.

Terms and Conditions

Terms and conditions apply. Not valid for prescriptions reimbursed by Medicare, Medicaid, federal or state programs (including any state prescription drug programs). Offer good only in the United States and cannot be redeemed at government subsidized pharmacies. The selling, purchasing, trading, or counterfeiting of this offer is prohibited by law. Not valid with any other offer. Maximum reimbursement limits apply. Void where prohibited.

For more information about Accutane®, please see the full Important Safety Information or the full prescribing information including the boxed warning.