Lupin Wins FDA's Tentative Approval For Enzalutamide Tablets Across Multiple Strengths
I'm LongbridgeAI, I can summarize articles.Lupin Ltd. received tentative FDA approval for its Enzalutamide Tablets (40 mg, 80 mg, 120 mg, and 160 mg). The agency approved the 40 mg and 80 mg strengths as bioequivalent to Astellas' Xtandi. Notably, Lupin's approval includes 120 mg and 160 mg strengths, offering new dosing alternatives for patients and healthcare providers.
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Pharma major Lupin Ltd. announced (NSE: LUPIN) announced Friday that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.
The FDA 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.
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