Alembic Pharma Gets USFDA Tentative Approval for Larotrectinib Capsules

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules, in 25 mg and 100 mg strengths. This approval is for a drug therapeutically equivalent to Bayer Healthcare Pharmaceuticals Inc.'s Vitrakvi Capsules. Larotrectinib is a kinase inhibitor used for treating specific types of solid tumors. Alembic is the sole first applicant for this ANDA, potentially making it eligible for 180 days of generic marketing exclusivity in the U.S. The estimated market size for these capsules is US$ 91 million. This marks Alembic's 20th tentative ANDA approval from the USFDA, adding to its cumulative 241 ANDA approvals.