Lupin Limited (Lupin) the Mumbai, India based global pharma major earlier this week had announced that the company 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.
In the press released the brand clarified that 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 labelling. Although 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.
Lupin Limited is a global pharmaceutical leader from India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has 15 state-of-the-art manufacturing sites and 7 research centres globally, along with a dedicated workforce of over 24,000 professionals.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
