Lupin Receives Tentative U.S. FDA Approval for Enzalutamide Tablets
Global pharmaceutical major Lupin Limited (Lupin) has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) regarding its Abbreviated New Drug Application for Enzalutamide Tablets. The tablets are available in strengths of 40 mg, 80 mg, 120 mg, and 160 mg.The U.S. FDA's tentative approval specifically covers Lupin's Enzalutamide Tablets at 40 mg and 80 mg as being bioequivalent to the reference listed drug (RLD) Xtandi® Tablets, manufactured by Astellas for the indicated use.
In addition to matching the traditional strengths of Xtandi Tablets—40 mg and 80 mg—Lupin’s tentatively approved product will offer healthcare providers and patients alternative dosing options in 120 mg and 160 mg strengths.
The drug represents a key development for Lupin Limited, a global pharmaceutical company headquartered in Mumbai, India. The company specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
Lupin operates with a commitment to improving patient health outcomes. The company maintains 15 state-of-the-art manufacturing sites and 7 research centers globally. It has over 24,000 professionals dedicated to its operations and is committed through subsidiaries like Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
LUPIN Stock Price Movement
Shares of Lupin Limited on Thursday slipped by 0.81% to settle at ₹2343.5, as the pharmaceutical stock saw moderate weakness in trading. The equity traded a total of 317,469 shares during the previous session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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