Lupin Gets US FDA Approval for Diazepam Injection USP

Lupin Limited has announced the U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes. This approval signifies that Lupin's product is bioequivalent to the reference listed drug, Valium® Injection, and is indicated for anxiety management. The U.S. market for this product had estimated annual sales of USD 77.9 million as of May 2026. This approval is a significant step for Lupin in expanding its U.S. market presence in the central nervous system therapeutic area.