Mumbai-based drugmaker on Friday said it has received tentative approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Enzalutamide Tablets in strengths of 40 mg, 80 mg, 120 mg and 160 mg.
The US FDA has tentatively approved Lupin’s Enzalutamide Tablets in 40 mg and 80 mg strengths as bioequivalent to the reference listed drug (RLD), Xtandi Tablets of Astellas, for the indication in the approved labelling.
While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin said its tentatively approved 120 mg and 160 mg tablet strengths will provide healthcare providers and patients with alternative dosing options.
Lupin, headquartered in Mumbai, distributes its products in more than 100 markets and has a portfolio spanning branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients.
The company has 15 manufacturing sites and seven research centres globally. It also operates through subsidiaries including Lupin Diagnostics, Lupin Digital Health and Lupin Manufacturing Solutions.