Global pharmaceutical giant Lupin Limited has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets. The approval covers strengths of 40 mg, 80 mg, 120 mg, and 160 mg. The 40 mg and 80 mg tablets are bioequivalent to Astellas’ Xtandi® Tablets, while the higher strengths offer new dosing options. This marks a significant step for Lupin in the U.S. market.
Lupin Secures FDA Tentative Approval for Enzalutamide Tablets
Global pharmaceutical major Lupin Limited announced on June 26, 2026, that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets. The approval encompasses multiple strengths: 40 mg, 80 mg, 120 mg, and 160 mg.
Bioequivalence and New Dosing Options
Lupin’s 40 mg and 80 mg Enzalutamide Tablets have been deemed bioequivalent to the reference listed drug (RLD), Xtandi® Tablets by Astellas Pharma Inc., for the approved indications. Notably, while Xtandi® Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin’s tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with valuable alternative dosing options. This development is expected to enhance treatment flexibility and patient compliance.
About Lupin Limited
Lupin Limited is a prominent global pharmaceutical leader headquartered in Mumbai, India. The company distributes its products across over 100 markets worldwide. Lupin specializes in a diverse range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs). The company holds a strong market presence in India and the U.S. across various therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin is committed to advancing patient health outcomes. Its subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Source: BSE
