Mumbai, June 19 -- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array. Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

The company had earlier received tentative approval for the 15 mg strength of the drug. Alembic stated that it is the sole first applicant for the 45 mg strength under a Paragraph IV certification filed under the Hatch-Waxman Act. Upon final appro...