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Fougera has introduced clotrimazole and betamethasone dipropionate cream USP 1%. The product is AB-rated to …
BETHESDA, MD. — A prominent warning that Lotrisone should not be used in children under age 12 or for diaper dermatitis should be added to the tube and box of the product, an expert panel has recommended.
At a meeting of the Food and Drug Administration’s Dermatologic and Ophthalmic Drugs Advisory Committee, the panel and guest experts discussed the labeling of Lotrisone cream–a combination of the steroid betamethasone dipropionate and the antifungal clotrimazole that has been on the market since 1984–and a lotion formulation that the FDA has deemed “approvable.” Lotrisone is manufactured by Schering-Plough Inc.
Taro Pharmaceuticals recently announced FDA approval of clotrimazole and betamethasone dipropionate cream, USP (C/B cream), the first generic equivalent to Lotrisone Cream to market. Taro’s new product is a combination antifungal and corticosteroid used in the treatment of a variety of dermatological conditions.
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