Approval for Larotrectinib Capsules, 25 mg and 100 mg - Alembic Ltd

Code BSE: 506235 NSE: $ALEMBICLTD US Food & Drug Administration (USFDA) Tentative Approval for Larotrectinib Capsules, 25 mg and 100 mg Based on the most recent update to the FDA’s online Paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules (25 mg and 100 mg), 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 U.S.