Alembic Pharmaceuticals (Alembic) today announced that its joint venture Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Nystatin and
Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1 %, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
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