Lupin Receives US FDA Approval for Diazepam Injection USP Prefilled Syringes
Lupin Limited received U.S. FDA approval for its Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes. The product is bioequivalent to Valium® Injection and is indicated for anxiety disorders. The U.S. market for this drug had estimated annual sales of USD 77.9 million (₹647.9 crore) as of May 2026.
The approval of a product with substantial market sales (USD 77.9 million) is likely to have a noticeable positive impact on Lupin's revenue and market presence in the United States.
The U.S. FDA approval of Diazepam Injection USP is a positive development for Lupin, expanding its product portfolio in a significant market.
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 was granted under the Federal Food, Drug, and Cosmetic Act. The U.S. FDA has confirmed that Lupin's Diazepam Injection USP is bioequivalent to the reference listed drug, Valium® Injection 10 mg/2 mL (5 mg/mL) from Hoffman-LaRoche, Inc. The injection is indicated for managing anxiety disorders and providing short-term relief of anxiety symptoms. The estimated annual sales for Diazepam Injection USP in the U.S. were USD 77.9 million as of May 2026, according to IQVIA data.
Lupin, a global pharmaceutical company headquartered in Mumbai, India, has a presence in over 100 markets. The company focuses on pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin holds a strong market position in India and the U.S. across various therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. The company operates 15 manufacturing sites and 7 research centers globally, employing over 24,000 professionals. Lupin is committed to enhancing patient health outcomes through its subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
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