Lupin receives USFDA approval for Diazepam Injection USP

Lupin 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).