Alembic Pharma Gets USFDA Tentative Nod for $259 M Binimetinib Tablets

Alembic Pharmaceuticals received USFDA tentative approval for Binimetinib Tablets, 45 mg, therapeutically equivalent to Mektovi. As the sole first applicant with a Paragraph IV certification, Alembic may secure 180 days of US generic marketing exclusivity upon final approval. The drug has an estimated market size of US$259 million.