Alembic Pharmaceuticals’ joint venture (JV) -- 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 Cream USP, 100,000 units/gram and 1 mg/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 • units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatinsteroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Nystatin and Triamcinolone Acetonide Cream, USP has an estimated market size of $ 19 million for twelve months ending December 2020. The company has a cumulative total of 139 ANDA approvals (123 final approvals and 16 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
