MUMBAI, India, and NAPLES, Fla.– Global pharmaceutical leader Lupin Limited today announced approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 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) from Hoffman-LaRoche, Inc. 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), in Single-Dose Prefilled Syringes, had estimated annual sales of USD 77.9 million in the U.S. (IQVIA MAT May 2026).
To know more, visit www.lupin.com or follow on LinkedIn https://www.linkedin.com/company/lupin
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