Alembic Pharma receives USFDA approval for lung cancer drug Binimetinib
Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Binimetinib tablets for treatment of lung cancer. The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product, Mektovi Tablets (15 mg), of Array BioPharma Inc, the company said in a regulatory filing on Saturday. Alembic is eligible for 180 days of generic drug exclusivity for Binimetinib Tablets, 15…




