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News 2026-10-08 19:18 UTC

Lupin wins FDA approval for Phytonadione injectable

Lupin said the U.S. FDA approved its ANDA for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe. The product is bioequivalent to the reference listed drug and is indicated for hypoprothrombinemia and vitamin K deficiency prophylaxis.