Mumbai, June 11 -- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc. (Bayer).

Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that harbor a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. The therapy is intended for patients with metastatic disease or those for whom surgical resection is likely to result in severe morbidity, and who have either no satisfactory alternative treatment options or whose disease has progressed following prior treatment.

Alembic Pharmaceuticals is a vertically integrated re...