Lupin Limited has received 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 makes Lupin’s product bioequivalent to the reference listed drug, Valium® Injection. The U.S. market for this indication had estimated annual sales of USD 77.9 million as of May 2026.
US FDA Approval Secured for Diazepam Injection
Global pharmaceutical major Lupin Limited announced today that it has received approval from the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for its Abbreviated New Drug Application (ANDA). The approval is for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes.
Bioequivalence and Market Opportunity
Lupin’s Diazepam Injection USP is bioequivalent to the reference listed drug (RLD) Valium® Injection from Hoffman-LaRoche, Inc. The drug is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. The estimated annual sales for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes in the U.S. were approximately USD 77.9 million for the period ending May 2026, according to IQVIA data.
About Lupin Limited
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has a strong presence in India and the U.S. across various therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company operates 15 state-of-the-art manufacturing sites and 7 research centers globally, with a workforce exceeding 24,000 professionals.
Source: BSE
