India, June 26 -- 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 m...