Key Development
Lupin Limited announced it 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 approval was granted on July 31, 2026.
Product Specifications
The U.S. FDA 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) of Hoffman-LaRoche, Inc.
Medical Indication
The product is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Market Size
Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes had estimated annual sales of USD 77.9 million in the U.S. based on IQVIA MAT May 2026 data.
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has 15 manufacturing sites and 7 research centers globally, with over 24,000 professionals. The company maintains strong positions in India and the U.S. across multiple therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Corporate Structure
Lupin operates through subsidiaries including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Trademark Notice
VALIUM® is a registered trademark of Atnahs Pharma US Limited.