Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the exclusive launch of two strengths of a generic version of Solodyn®1 (minocycline HCl) Extended Release Tablets, 65 and 115 mg, in the U.S.
Minocycline Hydrochloride Extended-Release Tablets are a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
With nearly 600 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 over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Solodyn® Extended Release Tablets, 65 and 115 mg, had annual sales of approximately $148 million in the U.S., according to IMS data as of December 2017.
About Minocycline Hydrochloride Extended-Release Tablets
Important Safety Information
Minocycline Hydrochloride Extended-Release Tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
TETRACYCLINE-CLASS DRUGS SHOULD NOT BE USED DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY AND UP TO 8 YEARS OF AGE) AS THEY MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH.
In clinical trials, the most commonly observed adverse reactions (incidence ≥ 5%) were headache, fatigue, dizziness, and pruritus.
About Teva
Cautionary Note Regarding Forward-Looking Statements
1 Solodyn® is a registered trademark of Valeant Pharmaceuticals International, Inc.
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