Aleor Dermaceuticals receives US FDA final approval for Nystatin and Triamcinolone Acetonide Ointment

Alembic Pharmaceuticals today announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (FDA) 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 per cent, of Taro Pharmaceuticals, Alembic Pharma notified in a statement.

The statement further said that 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.

Nystatin and Triamcinolone Acetonide Ointment has an estimated market size of $4 million for twelve months ending Dec 2021 according to IQVIA, added the statement.