Alembic Pharma Gets USFDA Final Approval for Venetoclax Tablets

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets in 10mg, 50mg, and 100mg strengths. This approval makes the ANDA therapeutically equivalent to AbbVie Inc.'s Venclexta Tablets. Venetoclax is used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) in certain adult patients. Alembic was a first ANDA applicant and may be eligible for 180 days of generic drug exclusivity. The US market for these tablets was estimated at $1,584 million for the twelve months ending June 2026. This marks Alembic's 228th final ANDA approval from the USFDA.