Lupin received U.S. FDA tentative approval for generic enzalutamide tablets in four strengths, including new 120 mg and 160 mg formulations, expanding its U.S. oncology portfolio for advanced prostate cancer.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Lupin Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths.
The FDA determined that Lupin’s 40 mg and 80 mg tablets are bioequivalent to Xtandi® (enzalutamide) Tablets, the reference listed drug marketed by Astellas. While Xtandi is commercially available in 40 mg and 80 mg strengths, Lupin’s application also includes 120 mg and 160 mg tablets, offering additional dosing options following final approval.
Enzalutamide in Advanced Prostate Cancer
Enzalutamide is an oral androgen receptor inhibitor used to treat advanced prostate cancer. By blocking androgen receptor signaling, it slows the growth and spread of prostate cancer cells.
The therapy is approved for multiple indications, including metastatic castration-resistant prostate cancer (mCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and selected patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It remains a standard component of treatment across several stages of advanced disease.
Regulatory Significance
An ANDA approval requires manufacturers to demonstrate pharmaceutical equivalence and bioequivalence to the reference product. Tentative approval indicates that Lupin’s application satisfies the FDA’s quality, manufacturing, and bioequivalence requirements but cannot receive final approval until applicable patent or exclusivity protections expire.
The approval strengthens Lupin’s U.S. oncology pipeline and expands its portfolio of complex generic medicines. Generic competition can improve patient access to established cancer therapies once market exclusivity ends.
Path Forward
Lupin expects to receive final FDA approval after all regulatory exclusivity and patent requirements associated with Xtandi have been resolved. The company will then be positioned to launch its generic enzalutamide tablets in the United States, further expanding treatment options for patients with advanced prostate cancer.
Reference
Lupin Receives Tentative Approval from U.S. FDA for Enzalutamide Tablets – Lupin | Press Release
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.
