Global pharmaceutical major Lupin Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes.

The approved product has been determined to be bioequivalent to the reference listed drug Valium Injection 10 mg/2 mL (5 mg/mL) marketed by Hoffmann-La Roche Inc. It is indicated for the management of anxiety disorders and the short-term relief of anxiety symptoms.

According to IQVIA MAT data for May 2026, the reference product recorded estimated annual sales of US$77.9 millionin the U.S., providing Lupin with an opportunity to strengthen its injectable product portfolio in the American market.

The approval adds to Lupin's growing pipeline of complex injectable products in the U.S., one of its key global markets, as the company continues to expand its portfolio of generic medicines with differentiated drug delivery formats.