The USFDA approved Lupin’s product as bioequivalent to the reference listed drug (RLD) Valium Injection 10 mg/2 mL (5 mg/mL) of Hoffmann-La Roche Inc. The product is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety, the company said.
According to IQVIA MAT May 2026 data, Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), single-dose prefilled syringes had estimated annual sales of $77.9 million in the United States.
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Earlier today, Lupin received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) and launched Sugammadex Injection in the United States.
The company has launched Sugammadex Injection in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial presentations.
Lupin said its product is bioequivalent to Merck’s Bridion Injection and is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and paediatric patients aged two years and older undergoing surgery.
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The launch follows approval of the company’s ANDA by the USFDA, Lupin said. Sugammadex is used to reverse the effects of certain muscle relaxants administered during surgical procedures, helping patients recover muscle function after anaesthesia.
Lupin, headquartered in Mumbai, markets branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients across more than 100 markets.
Shares of Lupin Ltd ended at ₹2,418.30, down by ₹0.80, or 0.033%, on the BSE.
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