Alembic Pharma Gets USFDA Nod for Tretinoin Cream USP, 0.05%

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%. This generic drug is therapeutically equivalent to Retin-A Cream, 0.05%, and is used for treating acne vulgaris. The estimated market size for this product is US$ 76 million. This approval adds to Alembic's portfolio, bringing their total USFDA ANDA approvals to 242.