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Lupin Receives U.S. FDA Tentative Approval for Enzalutamide Tablets

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Indian pharmaceutical major Lupin Limited (NSE:LUPIN, BOM:500257) has secured tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for enzalutamide tablets, according to a Friday regulatory filing

The clearance encompasses 40 mg, 80 mg, 120 mg, and 160 mg strengths of the oncology therapeutic. The 40 mg and 80 mg iterations have been deemed bioequivalent to the reference listed drug Xtandi(r) tablets, manufactured by Japan's Astellas Pharma, for the indications detailed in the approved label.

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