Lupin Secures USFDA Approval for Diazepam Injection USP in Prefilled Syringes
New Delhi: Global pharmaceutical company Lupin Limited has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes.
The approved product is bioequivalent to the reference listed drug (RLD), Valium Injection 10 mg/2 mL (5 mg/mL) of Hoffmann-La Roche Inc.
According to the company, Diazepam Injection USP is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety.
Lupin said the approved product had estimated annual sales of USD 77.9 million in the United States for the 12-month period ending May 2026, according to IQVIA MAT data.
The approval further expands Lupin's portfolio of injectable products in the US market and strengthens its presence in the generics segment.
Mumbai-headquartered Lupin is a global pharmaceutical company with operations in more than 100 markets. Its portfolio includes branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients (APIs), with a strong presence in therapeutic areas including respiratory, cardiovascular, diabetes, anti-infectives, gastrointestinal, central nervous system and women's health.
