Key Development
Lupin Limited announced 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 in four strengths: 40 mg, 80 mg, 120 mg, and 160 mg.
Product Specifics
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 Pharma Inc. for the indication described in the approved labeling. The approval includes additional strengths of 120 mg and 160 mg, which will provide healthcare providers and patients with alternative dosing options beyond the traditional 40 mg and 80 mg strengths available for Xtandi Tablets.
Company Background
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has 15 manufacturing sites and 7 research centers globally, with over 24,000 professionals.
Trademark Notice
Xtandi® is a registered trademark of Astellas Pharma Inc.