Lupin today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.
The U.S. FDA has tentatively approved Lupin's Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi® Tablets of Astellas for the indication in the approved labeling. While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin's tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with alternative dosing options. |