Alembic Pharma JV gets USFDA nod to Nystatin and Triamcinolone Acetonide Cream
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Mumbai: Drug major, Alembic Pharmaceuticals Limited, today announced that the company's joint venture Aleor Dermaceuticals Limited 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 nystatin-steroid 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 US$ 19 million for twelve months ending December 2020 according to IQVIA.
Alembic has a cumulative total of 139 ANDA approvals (123 final approvals and 16 tentative approvals) from USFDA.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
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