Alembic Pharmaceuticals Receives USFDA Tentative Approval for Generic Binimetinib Tablets
Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its generic Binimetinib Tablets, 45 mg, used in combination with encorafenib to treat unresectable or metastatic melanoma and metastatic non-small cell lung cancer with specific BRAF mutations. Alembic is the sole first applicant for this strength under a Paragraph IV certification and may gain 180 days of marketing exclusivity upon final approval. The Binimetinib market is estimated at USD 259 million for the year ending March 2026.