Lupin gets tentative nod from US FDA for Enzalutamide tablets
The tentative approval covers the 40 mg, 80 mg, 120 mg, and 160 mg strengths
Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.
The US 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, informed the company.