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Lupin gets USFDA’s tentative approval for Enzalutamide Tablets

27 Jun 2026 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.

The USFDA has tentatively approved Lupin’s Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi Tablets of Astellas for the indication in the approved labeling. 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 alternative dosing options.

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


Lupin Share Price

2342.15 -25.65 (-1.08%)
25-Jun-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma. Inds. 1862.15
Dr. Reddys Labs. 1350.00
Cipla 1440.30
Zydus Lifesciences 1101.50
Lupin 2342.15
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