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|July 28, 2017 8:00 a.m.|
|Teva Announces Launch of Generic Epiduo® in the United States|
Adapalene and benzoyl peroxide gel 0.1%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
“I am very pleased that Teva is introducing another first generic
product, bringing value to our patients and savings to the US healthcare
Teva was the first company to file a generic application for Epiduo and is expected to benefit from 180-days of generic product exclusivity. This launch marks the most recent addition to Teva’s portfolio of over 40 dermatology products.
“This is an extremely important development for Teva in our desire to make a meaningful difference to the millions of patients who suffer from acne in the U.S.,” said Hafrun Fridriksdottir, Ph.D., EVP, President of Global Generics R&D.
With close to 600 generic medicines available, Teva has the largest
Adapalene and benzoyl peroxide gel 0.1%/2.5% had annual sales of
About Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%
Adapalene and benzoyl peroxide gel 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Important Safety Information
Exposure to sunlight, including sunlamps, should be minimized during use. Patients with high levels of sun exposure and those with inherent sensitivity to sun should exercise particular caution. Use of sunscreen products and protective apparel are recommended when exposure cannot be avoided. Erythema, scaling, dryness, and stinging/burning may be experienced with use. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Irritant and allergic contact dermatitis may occur. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. Avoid concomitant use of other potentially irritating topical products. In clinical trials, the most commonly reported adverse events (greater than or equal to 1%) were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation.
For more information, please see accompanying Full Prescribing Information.
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 and potential benefits of Teva's generic version of Epiduo®, 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:
and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned "Risk Factors," and in our other filings with the U.S. Securities and Exchange Commission which are available at www.sec.gov and www.tevapharm.com. 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® is a registered trademark of
Teva Pharmaceutical Industries Ltd.