Lupin Secures USFDA Approval for Diazepam Injection USP in Prefilled Syringes
Written By : sheeba farhat
Published On 2026-08-01 08:00 GMT | Update On 2026-08-01 08:00 GMT
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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.
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