Lupin Limited has received tentative approval from the U.S. FDA for its generic Enzalutamide Tablets. The approval covers 40 mg, 80 mg, 120 mg, and 160 mg strengths under an Abbreviated New Drug Application. The 40 mg and 80 mg strengths are bioequivalent to Astellas' Xtandi, the reference listed drug for prostate cancer treatment. Lupin's additional 120 mg and 160 mg options aim to provide more dosing flexibility for healthcare providers. Lupin closed Friday's trading at INR 2,346.00, down 0.92%.
Astellas Pharma Inc.Lupin's generic Enzalutamide, including bioequivalent versions to Astellas' Xtandi, gains tentative FDA approval, threatening Astellas' market share.