Lupin Gets USFDA Approval for Vitamin K Injection Used to Treat Low Blood Clotting
Mumbai: Lupin Limited 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, in a single-dose prefilled syringe.
The USFDA approved the product as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, marketed by International Medication Systems, Limited.
Also Read: Lupin Gets Tentative USFDA Approval for Apixaban Oral Suspension
Phytonadione injection is indicated for the treatment and prophylaxis of hypoprothrombinemia, a condition characterised by low blood-clotting ability, and vitamin K deficiency.
According to IQVIA MAT data for August 2026, Phytonadione Injectable Emulsion had estimated annual sales of USD 52.3 million in the United States.
