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Actavis applies for approval of generic version of Absorica
DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.
The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy's Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.
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Actavis seeks approval for generic acne drug
DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.
The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.