The product is a generic version of Taro Pharmaceuticals USA Inc’s Nystatin and Triamcinolone Acetonide cream USP in the same strength
Alembic Pharmaceuticals said its joint venture Aleor Dermaceuticals has received a final nod from the US health regulator for antifungal Nystatin and Triamcinolone Acetonide cream used for the treatment of cutaneous candidiasis.
Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Nystatin and Triamcinolone Acetonide cream USP, 1,00,000 units/gram and 1 mg/gram, Alembic Pharma said in a BSE filing.
The product is a generic version of Taro Pharmaceuticals USA Inc’s Nystatin and Triamcinolone Acetonide cream USP in the same strength, it added.
According to IQVIA, Nystatin and Triamcinolone Acetonide cream USP has an estimated market size of USD 19 million for twelve months ending December 2020, the filing said.
Nystatin and Triamcinolone Acetonide cream USP is indicated for the treatment of cutaneous candidiasis, it added.
The company has a cumulative total of 139 ANDA approvals (123 final approvals and 16 tentative approvals) from the US FDA, Alembic Pharma said.
PTI
