Lupin receives Tentative Approval from U.S. FDA for Enzalutamide Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg.

The U.S. FDA has tentatively approved Lupin's Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi® Tablets of Astellas for the indication in the approved labeling. 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 alternative dosing options.

Shares of Lupin Limited was last trading in BSE at Rs. 2342.15 as compared to the previous close of Rs. 2367.80. The total number of shares traded during the day was 18125 in over 2377 trades.

The stock hit an intraday high of Rs. 2389.90 and intraday low of 2336.90. The net turnover during the day was Rs. 42826159.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA TentativeApproval ANDA EnzalutamideTablets