FDA grants tentative approval to generic enzalutamide tablets

The FDA has granted tentative approval to an abbreviated new drug application (ANDA) for generic enzalutamide tablets in 40-mg, 80-mg, 120-mg, and 160-mg strengths, Lupin Limited reported in a company announcement.¹

The tentative decision positions the company to potentially expand future generic access to the androgen receptor pathway inhibitor (ARPI) following expiration of applicable exclusivity protections. The tentative approval includes bioequivalence for the 40-mg and 80-mg tablet strengths to the reference listed drug (RLD), Xtandi (enzalutamide; Astellas), while the company's proposed 120-mg and 160-mg formulations represent additional tablet strengths not currently available for the branded product.

Lupin's application was submitted through the FDA's ANDA pathway, which requires demonstration that a proposed generic product is pharmaceutically equivalent and bioequivalent to the branded reference product.²

Clinical context

Enzalutamide is an oral ARPI that is indicated across multiple stages of advanced prostate cancer. Since its initial FDA approval in 2012 for metastatic castration-resistant prostate cancer (mCRPC), its labeled indications have expanded to include nonmetastatic CRPC, metastatic castration-sensitive prostate cancer (mCSPC), and selected patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.³

REFERENCES

1. Lupin receives tentative approval from U.S. FDA for enzalutamide tablets. News release. Lupin Limited. June 26, 2026. Accessed June 26, 2026. https://www.prnewswire.com/news-releases/lupin-receives-tentative-approval-from-us-fda-for-enzalutamide-tablets-302811905.html

2. Abbreviated New Drug Application (ANDA). US Food & Drug Administration. Accessed June 26, 2026. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

3. Xtandi milestones. Accessed June 26, 2026. https://www.xtandihcp.com/about-xtandi/milestones