Lupin receives USFDA approval for Phytonadione Injectable Emulsion
The product is indicated for the treatment and prophylaxis of hypoprothrombinemia and vitamin K deficiency
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.