India-based global pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Tuesday 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 US Food and Drug Administration (FDA) has approved the product as bioequivalent to the reference listed drug (RLD), Valium Injection 10 mg/2 mL (5 mg/mL) of Hoffman-LaRoche Inc (SIX:RO). It 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 USD77.9m in the United States (IQVIA MAT May 2026).