Alembic Pharma gets USFDA Tentative Approval for Binimetinib Tablets

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. This drug, used in combination with encorafenib, treats specific types of melanoma and non-small cell lung cancer. Alembic is the sole first applicant for this dosage, potentially making it eligible for 180 days of generic marketing exclusivity upon final approval. The estimated market size for Binimetinib Tablets is US$ 259 million. This approval adds to Alembic's portfolio of 242 USFDA ANDA approvals.