Lupin Gets USFDA Tentative Nod for Generic Prostate Cancer Drug Enzalutamide
New Delhi: Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg and 160 mg strengths.
According to the company, the U.S. FDA has tentatively approved Lupin's Enzalutamide Tablets, 40 mg and 80 mg, as bioequivalent to the Reference Listed Drug (RLD), Xtandi Tablets, marketed by Astellas, for the indication specified in the approved labeling.
The company further stated that 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 additional dosing options, expanding treatment flexibility.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed across more than 100 markets worldwide. It specializes in branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients (APIs). The company has established a strong presence in India and the United States across multiple therapeutic areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system and women's health.
Lupin currently operates 15 state-of-the-art manufacturing facilities and seven research centres globally, supported by a workforce of more than 24,000 professionals. The company stated that it remains committed to improving patient health outcomes through its subsidiaries Lupin Diagnostics, Lupin Digital Health and Lupin Manufacturing Solutions. The press release also notes that Xtandi is a registered trademark of Astellas Pharma Inc.
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