India-based global pharmaceutical company Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) announced on Friday that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg and 160 mg.
The US FDA has tentatively approved Lupin's Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to Astellas's reference listed drug (RLD) Xtandi Tablets for the indication in the approved labelling.
While Xtandi Tablets are traditionally available in 40mg and 80mg strengths, Lupin's tentatively approved 120mg and 160mg strengths will provide healthcare providers and patients with alternative dosing options.
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