TEL AVIV & PARSIPPANY, N.J.–(BUSINESS WIRE)– 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.