Teva Announces the Launch of the First Generic Version of Absorica® (isotretinoin) Capsules, for the Treatment of Severe Recalcitrant Nodular Acne in Patients 12 Years of Age and Older, in the United States
“Teva’s first-to-market generic version of Absorica® (isotretinoin) capsules in the U.S. is an important treatment option for patients living with severe recalcitrant nodular acne, and who are unresponsive to conventional acne therapy, including antibiotics,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. “With more than 30 dermatological products in Teva’s generics portfolio, we are proud to add another accessible option for patients.”
With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Currently, 1 in 11 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Isotretinoin oral capsules have annual sales of more than $158 million in the U.S., according to IQVIA data as of February 2021.
About Isotretinoin Oral Capsules
Isotretinoin capsules are prescription medicines used in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics.
It is not known if isotretinoin capsules are safe and effective in children less than 12 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about isotretinoin capsules?
- Isotretinoin capsules 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 isotretinoin capsules.
Patients must not get pregnant:
- for 1 month before starting isotretinoin capsules
- during treatment with isotretinoin capsules
- for 1 month after stopping isotretinoin capsules
If you get pregnant during treatment with isotretinoin capsules, stop taking it right away and call your healthcare provider. Healthcare providers and patients should report all cases of pregnancy during treatment or 1 month after stopping treatment to:
- FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch, and
- the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com
Because isotretinoin capsules can cause birth defects, isotretinoin capsules are only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE Program.
- Serious mental health problems, including:
- psychosis(seeing or hearing things that are not real)
- suicide. Some patients taking isotretinoin capsules have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. Some people have ended their own lives.
Stop taking isotretinoin capsules and call your healthcare provider 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
Your healthcare provider may tell you to see a mental healthcare professional if you had any of these symptoms.
Do not take isotretinoin capsules if you:
- are pregnant, plan to become pregnant, or become pregnant during isotretinoin capsules treatment. Isotretinoin capsules cause severe birth defects. See “What is the most important information I should know about isotretinoin capsules?”
- are allergic to isotretinoin, vitamin A, or any of the ingredients in isotretinoin capsules. See the end of the Medication Guide in the full Prescribing Information for a complete list of ingredients in isotretinoin capsules.
Before taking isotretinoin capsules, tell your healthcare provider if you or a family member has any of the following health conditions:
- mental health problems
- liver problems
- heart disease
- increase blood fat levels (cholesterol and triglycerides)
- bone loss (osteoporosis), weak bones or any other bone problems
- an eating problem called anorexia nervosa (where people eat too little)
- food or medicine allergies, including aspirin or tartrazine
Tell your healthcare provider if you are pregnant or breastfeeding. Do not breastfeed during treatment or for at least 8 days after the last dose of isotretinoin capsules.
Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements, including St. John’s wort. Isotretinoin capsules and certain other medicines can affect each other, sometimes causing serious side effects.
Do not take the following medicines during treatment with isotretinoin capsules:
- vitamin A supplements
- tetracycline antibiotics
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist. Do not take any new medicine without talking with your healthcare provider.
What should I avoid while taking isotretinoin capsules?
- Do not give blood during treatment with isotretinoin capsules and for one month after stopping isotretinoin capsules. If someone who is pregnant gets your donated blood, their baby may be exposed to isotretinoin and may be born with birth defects.
- Do not take other medicines or herbal products with isotretinoin capsules unless you talk to your healthcare provider. See “Before taking isotretinoin capsules”
- Do not drive at night until you know if isotretinoin capsules have affected your vision. Isotretinoin capsules may decrease your ability to see in the dark.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, during treatment with isotretinoin capsules and for at least 6 months after you stop. Isotretinoin capsules can increase your chance of scarring from these procedures. Check with your healthcare provider for advice about when you can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Isotretinoin capsules may make your skin more sensitive to light.
- Do not share isotretinoin capsules with other people. Isotretinoin capsules can cause birth defects and other serious health problems.
What are the possible side effects of isotretinoin capsules?
Isotretinoin capsules can cause serious side effects, including:
- See “What is the most important information I should know about isotretinoin capsules?”
- increased pressure in the brain (intracranial hypertension). Isotretinoin capsules can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking isotretinoin capsules and call your healthcare provider right away if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea or vomiting, seizures (convulsions), or stroke.
- serious skin problems. Skin rash can occur in patients taking isotretinoin capsules. Sometimes rash can be serious and may lead to death. Stop using isotretinoin capsules and call your healthcare provider right away if you get: conjunctivitis (red or inflamed eyes, like “pink eye”); rash with a fever; blisters on legs, arms or face; sores in your mouth, throat, nose or eyes; or peeling of your skin.
- inflammation of your pancreas (pancreatitis) can happen in patients who take isotretinoin capsules and can lead to death. Call your healthcare provider right away if you have any of the following symptoms of pancreatitis: severe upper stomach (abdomen) pain, swelling of your stomach, nausea and vomiting, or fever.
- increased blood fat (lipid) levels. Isotretinoin capsules can raise blood fat levels (cholesterol and triglycerides). Your healthcare provider will do blood tests to check your lipids before and during treatment. These problems usually go away when isotretinoin capsules treatment is finished.
- hearing problems. Stop using isotretinoin capsules and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
- liver problems, including hepatitis. Your healthcare provider will do tests to check your liver before and during treatment with isotretinoin capsules. Call your healthcare provider if you get: yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area (abdomen), dark urine, bleeding or bruising more easily than normal.
- inflammation of your digestive tract (inflammatory bowel disease).Stop taking isotretinoin capsules and call your healthcare provider if you get: severe stomach, chest or bowel pain; nausea or vomiting; trouble swallowing or painful swallowing; new or worsening heartburn; diarrhea; or rectal bleeding.
- bone and muscle problems. Bone problems include bone pain, softening or thinning (which may lead to fractures). Tell your healthcare provider if you plan hard physical activity during treatment with isotretinoin capsules. Tell your healthcare provider if you get: back pain, joint pain or muscle pain, or a broken bone. Tell all healthcare providers that you take isotretinoin capsules if you break a bone.
Stop isotretinoin capsules and call your healthcare provider right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
Isotretinoin capsules may stop long bone growth in teenagers who are still growing.
- vision problems. Stop taking isotretinoin capsules and call your healthcare provider right away if you have any vision changes. Isotretinoin capsules may affect your ability to see in the dark. This usually goes away after you stop taking isotretinoin capsules, but it may be permanent. Some patients get dry eyes during treatment. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with isotretinoin capsules.
- serious allergic reactions. Stop taking isotretinoin capsules and get emergency medical help right away if you get hives, a swollen face or mouth, or have trouble breathing. Stop taking isotretinoin capsules and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
- blood sugar problems, including diabetes. Tell your healthcare provider if you are very thirsty or urinate more than usual.
The most common side effects of isotretinoin capsules include:
- dry lips
- dry skin
- back pain
- dry eyes
- joint pain
- nose bleeds
- upper respiratory tract infection (common cold)
- chapped lips or swelling of the lips
- skin reactions
- muscle problems
- eye problems, including decreased vision
These are not all of the possible side effects of isotretinoin capsules. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see accompanying full Prescribing Information. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872), email@example.com, or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of our 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strength generic Isotretinoin oral capsules in the United States, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
- the commercial success of our 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strength generic Isotretinoin oral capsules;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
- other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
1 Absorica® is a registered trademark of Sun Pharmaceutical Industries Inc.
Kevin C. Mannix (215) 591-8912
Yael Ashman 972 (3) 914-8262
Kelley Dougherty (973) 658-0237
Yonatan Beker 972 (54) 888 5898
Source: Teva Pharmaceutical Industries Limited