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Alembic received USFDA final approval for Binimetinib Tablets 15 mg and 45 mg, generic to Mektovi for BRAF-mutant melanoma and NSCLC with encorafenib, eligible for 180-day exclusivity as sole first applicant for 45 mg, $282 million market, cumulative ANDA approvals at 248.
Alembic Pharmaceuticals Secures USFDA Final Approval For $1.6 Billion Venetoclax With Exclusivity
Alembic Partner Natco Receives USFDA Tentative Approval For $1.4 B Olaparib
Alembic Pharma Gets USFDA Tentative Nod for $259 M Binimetinib Tablets
Alembic Pharma Receives USFDA Tentative Approval for Larotrectinib Capsules