Lupin Limited has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Enzalutamide Tablets. The approval covers 40 mg, 80 mg, 120 mg, and 160 mg strengths and was announced through a press release on June 26, 2026.
The US FDA has tentatively approved Lupin's Enzalutamide Tablets in 40 mg and 80 mg strengths as bioequivalent to the reference listed drug Xtandi Tablets of Astellas. The approved indication is consistent with the labeling of the reference product.
Lupin's tentatively approved 120 mg and 160 mg strengths offer additional dosing options beyond the traditional 40 mg and 80 mg strengths of Xtandi. These strengths provide healthcare providers and patients with greater flexibility in treatment regimens.
Enzalutamide is indicated for the treatment of prostate cancer. The tentative approval enables Lupin to expand its oncology product portfolio within the US generics market.
Lupin is a global pharmaceutical company headquartered in Mumbai, India, with products distributed across over 100 markets. Lupin specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients across therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Lupin operates 15 manufacturing sites and 7 research centers globally with a workforce of over 24,000 professionals. Lupin has a strong presence in both the India and US pharmaceutical markets.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.