Lupin gets US FDA's tentative nod for enzalutamide tablets
This story was originally published at 14:30 IST on 27 June 2026
Register to read our real-time news.Informist, Saturday, Jun. 27, 2026
--Lupin gets US FDA tentative nod for Enzalutamide tablets
MUMBAI – Lupin Ltd. has received tentative approval from the US Food and Drug Administration for its abbreviated new drug application for enzalutamide tablets of strength 40 milligrams, 80 milligrams, 120 milligrams, and 160 milligrams. The tablets are the bioequivalent of Xtandi tablets by the Japanese pharmaceutical company Astellas, Lupin said in an exchange filing Friday.
The tablets are traditionally available in 40 milligram and 80 milligram strengths. Lupin has got tentative approval for 120 milligram and 160 milligram strengths as well, which will give healthcare providers and patients more dosage options. Enzalutamide is used to treat patients with prostate cancer.
For the March quarter, on a consolidated basis, Lupin had reported a net profit of INR 14.60 billion on revenues of INR 74.75 billion. Thursday, its shares ended at INR 2,343.50 on the National Stock Exchange, down 1% from Wednesday. The stock market was shut Friday for Muharram. End
Reported by Ashvita Chalke
Edited by Rajeev Pai
For users of real-time market data terminals, Informist news is available exclusively on the NSE Cogencis WorkStation.
Cogencis news is now Informist news. This follows the acquisition of Cogencis Information Services Ltd. by NSE Data & Analytics Ltd., a 100% subsidiary of the National Stock Exchange of India Ltd. As a part of the transaction, the news department of Cogencis has been sold to Informist Media Pvt. Ltd.
Informist Media Tel +91 (22) 6985-4000
Send comments to feedback@informistmedia.com
© Informist Media Pvt. Ltd. 2026. All rights reserved.
To read more please subscribe
Share this Story:
