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Lupin receives USFDA approval for Phytonadione Injectable Emulsion
Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.
The USFDA has approved Lupin’s Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited.
The product is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K deficiency.
According to IQVIA MAT August 2026 data, Phytonadione Injectable Emulsion had estimated annual sales of USD 52.3 million in the US.
The post Lupin receives USFDA approval for Phytonadione Injectable Emulsion appeared first on Express Pharma.
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