Lupin Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths. The announcement was made on June 26, 2026, by the global pharmaceutical company headquartered in Mumbai, India, with U.S. operations in Naples, Florida.
Tentative Approval Details
The U.S. FDA tentatively approved Lupin’s Enzalutamide Tablets, 40 mg and 80 mg, as bioequivalent to the reference listed drug Xtandi Tablets by Astellas Pharma Inc. for the indications in the approved labeling. While Xtandi is traditionally available only in 40 mg and 80 mg strengths, Lupin’s tentatively approved 120 mg and 160 mg strengths offer healthcare providers and patients alternative dosing options.
According to Lupin, the tentative approval marks a significant step in expanding access to this important cancer therapy. Enzalutamide is used to treat certain types of prostate cancer.
About Lupin Limited
Lupin Limited is a global pharmaceutical leader with products distributed in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin holds a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
The company operates 15 state-of-the-art manufacturing sites and 7 research centers globally, with a workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Market Impact
The tentative approval positions Lupin to enter the U.S. market for enzalutamide once final approval is granted and patent exclusivities expire. The availability of higher strength tablets (120 mg and 160 mg) could simplify dosing regimens for patients, potentially improving adherence and outcomes. This development also underscores Lupin’s continued investment in complex generic products to address unmet medical needs.
Lupin noted that the tentative approval does not imply that the drug is currently available for marketing in the U.S. Final approval is subject to resolution of patent and exclusivity issues. The company did not provide a timeline for final approval.
