Tentative Approval for Binimetinib Tablets, 45 mg. - Alembic Ltd

Code 506235 NSE: $ALEMBICLTD Alembic Pharmaceuticals Limited receives USFDA Tentative Approval for Binimetinib Tablets, 45 mg. Based on FDA’s Paragraph IV Certifications List, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by the USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US.