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BusinessDalal Street Investment Journal

Lupin Secures USFDA Nod for Diazepam Injection, Targets USD 77.9 Million Market

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  1. Lupin Ltd received USFDA approval for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringes.

  2. The drug is a generic version of Valium Injection marketed by Hoffmann-La Roche Inc.

  3. It is indicated for management of anxiety disorders and short-term relief of anxiety symptoms.

  4. The reference product recorded estimated annual sales of USD 77.9 million in the US (IQVIA data, 12 months ended May 2026).

  5. The approval expands Lupin's injectable portfolio in the US generics market.

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