Lupin Gets Tentative FDA Nod For Enzalutamide Tablets

(RTTNews) - Lupin Limited (LUPIN) has received tentative approval from the U.S. FDA for its generic Enzalutamide Tablets, marking another step in the company's effort to expand its oncology portfolio in the U.S. market. The approval covers four tablet strengths and positions Lupin to offer additional dosing options once final approval is granted.

The FDA's tentative approval applies to Lupin's 40 mg, 80 mg, 120 mg, and 160 mg Enzalutamide Tablets under the Abbreviated New Drug Application (ANDA). The 40 mg and 80 mg strengths are bioequivalent to Astellas' Xtandi, the reference listed drug used in prostate cancer treatment.

While Xtandi is traditionally available only in 40 mg and 80 mg strengths, Lupin's additional 120 mg and 160 mg tablet options are designed to give healthcare providers more flexibility in prescribing and dosing regimens.

Lupin, headquartered in Mumbai with operations across more than 100 markets, remains one of India's largest pharmaceutical manufacturers, with a strong presence in the U.S. across multiple therapeutic areas including cardiovascular, respiratory, diabetes, and central nervous system disorders.

LUPIN closed Friday's trading at INR 2,346.00, down 0.92%.