Lupin Limited, a global pharmaceutical leader, has announced receiving tentative approval from the US FDA for its Enzalutamide Tablets. The approval covers 40 mg, 80 mg, 120 mg, and 160 mg strengths, providing alternative dosing options.
On June 26, 2026, Lupin Limited revealed it had secured tentative approval from the US FDA for its Abbreviated New Drug Application for Enzalutamide Tablets.
These tablets are available in 40 mg, 80 mg, 120 mg, and 160 mg strengths. The 40 mg and 80 mg tablets have been deemed bioequivalent to the reference listed drug, Xtandi® Tablets by Astellas.
While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin's tentative approval for 120 mg and 160 mg strengths offers healthcare providers and patients additional dosing options. This development aims to enhance treatment flexibility and patient care.
Lupin Limited is headquartered in Mumbai, India, and operates in over 100 markets globally. The company specialises in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
Lupin holds a strong position in India and the US across various therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
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Lupin boasts 15 state-of-the-art manufacturing sites and 7 research centres worldwide. The company employs over 24,000 professionals dedicated to improving patient health outcomes. Lupin's subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
As of June 25, 2026, at 3:30 PM, Lupin share price on NSE was closed at ₹2,343.50, down by 1.02% from the previous closing price.
Lupin Limited's tentative approval from the US FDA for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths marks a significant step in providing alternative dosing options. This approval aligns with Lupin's commitment to enhancing patient care and treatment flexibility.
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Published on: Jun 26, 2026, 12:05 PM IST
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