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Lupin secures FDA approval for Diazepam Injection, referencing $77.9 million U.S. sales
31-Jul-2026, 06:28
Lupin Limited announced it received approval from the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes, which is bioequivalent to Hoffman-LaRoche, Inc.’s Valium® Injection, and indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety; the product had estimated annual sales of USD 77.9 million in the U.S. (IQVIA MAT May 2026).
Lupin Limited announced it received approval from the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act for its Abbreviated New Drug Application for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes, which is bioequivalent to Hoffman-LaRoche, Inc.’s Valium® Injection, and indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety; the product had estimated annual sales of USD 77.9 million in the U.S. (IQVIA MAT May 2026).