Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the launch of an authorized generic of Epiduo®1 Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the United States.
Adapalene and benzoyl peroxide gel 0.3%/2.5% is a topical prescription medicine used to treat acne vulgaris.
“The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. “Continuing to advance and launch much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them."
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.
Epiduo® Forte Gel had annual sales of $253 million in the U.S., according to IQVIA data, as of September 2021.
IMPORTANT SAFETY INFORMATION
Adapalene and Benzoyl Peroxide gel is for use on the skin only (topical). Do not use Adapalene and Benzoyl Peroxide gel in or on your mouth, eyes, or vagina.
Before using Adapalene and Benzoyl Peroxide gel, tell your doctor about all of your medical conditions, including if you:
Have other skin problems, including cuts or sunburn
Are pregnant or plan to become pregnant. It is not known if Adapalene and Benzoyl Peroxide gel can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
Are breastfeeding or plan to breastfeed. It is not known if Adapalene and Benzoyl Peroxide gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use Adapalene and Benzoyl Peroxide gel.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using other topical acne products may increase the irritation of your skin when used with Adapalene and Benzoyl Peroxide gel.
What should I avoid while using Adapalene and Benzoyl Peroxide gel?
Avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene and Benzoyl Peroxide gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. Use sunscreen and wear a hat and clothes that cover the areas treated with Adapalene and Benzoyl Peroxide gel if you have to be in sunlight.
Cold weather and wind may irritate skin treated with Adapalene and Benzoyl Peroxide gel.
Avoid applying Adapalene and Benzoyl Peroxide gel to cuts, abrasions, and sunburned skin.
Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes.
Avoid the use of “waxing” as a hair removal method on skin treated with Adapalene and Benzoyl Peroxide gel.
Adapalene and Benzoyl Peroxide gel may bleach your clothes or hair. Allow Adapalene and Benzoyl Peroxide gel to dry completely before dressing to prevent bleaching of your clothes.
What are the possible side effects of Adapalene and Benzoyl Peroxide gel?
Adapalene and Benzoyl Peroxide gel may cause serious side effects including:
Local skin reactions. Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of Adapalene and Benzoyl Peroxide gel. Signs and symptoms of local skin reactions include redness, scaling, dryness, stinging, or burning.
Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse, you may have to stop using Adapalene and Benzoyl Peroxide gel.
These are not all the possible side effects of Adapalene and Benzoyl Peroxide gel. 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.
Please read the Patient Information Leaflet in the full Prescribing Information.
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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development, approval and commercialization of our generic products; 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 additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding 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; 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; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the section captioned “Risk Factors.” 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 Epiduo® Forte is a registered trademark of Galderma Laboratories, L.P
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