USFDA26 Jun 2026, 09:38 am
Lupin gets tentative US FDA nod for Enzalutamide Tablets
AI Summary
Lupin Limited has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths. The 40 mg and 80 mg strengths are bioequivalent to Astellas' Xtandi® Tablets. This approval offers alternative dosing options for healthcare providers and patients, potentially expanding Lupin's market presence in the oncology segment.
Key Highlights
- Lupin receives tentative US FDA approval for Enzalutamide Tablets.
- Approval covers multiple strengths including 40mg, 80mg, 120mg, and 160mg.
- Tentative approval for 40mg and 80mg strengths is bioequivalent to Xtandi®.
- New strengths offer alternative dosing options for patients and providers.
Price Impact
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