Lupin Announces the Approval of Diazepam Injection, USP in the United States

Global pharma major Lupin Limited (Lupin) today announced that it has received approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes.

The U.S. FDA has approved Lupin's Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes as bioequivalent to the reference listed drug (RLD) Valium® Injection 10 mg/2 mL (5 mg/mL) of Hoffman-LaRoche, Inc. and is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.

Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes had estimated annual sales of USD 77.9 million in the U.S. (IQVIA MAT May 2026).

Shares of Lupin Limited was last trading in BSE at Rs. 2413.95 as compared to the previous close of Rs. 2419.10. The total number of shares traded during the day was 30934 in over 2136 trades.

The stock hit an intraday high of Rs. 2433.70 and intraday low of 2405.00. The net turnover during the day was Rs. 74799387.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals Approval DiazepamInjection USA