Lupin receives tentative FDA approval for enzalutamide tablets

MUMBAI, India, and NAPLES, Fla. — Lupin Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg and 160 mg.

The company said the FDA tentatively approved Lupin’s Enzalutamide Tablets, 40 mg and 80 mg, as bioequivalent to Xtandi Tablets from Astellas, the reference listed drug, for the indication in the approved labeling.

While Xtandi Tablets are traditionally available in 40 mg and 80 mg strengths, Lupin said its tentatively approved 120 mg and 160 mg strengths will provide health care providers and patients with alternative dosing options.

Lupin, headquartered in Mumbai, India, distributes products in more than 100 markets and specializes in branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. The company has a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system and women’s health.

Lupin operates 15 manufacturing sites and seven research centers globally and employs more than 24,000 professionals.

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