Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (FDA) 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 US FDA
