Instant Report
FDF

Date: 02-Apr-2021

Aleor Gets US FDA Approval For Nystatin And Triamcinolone Acetonide Cream USP

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