Lupin Gets USFDA Approval for Vitamin K Injection Used to Treat Low Blood Clotting
October 9, 2026
Original source summary
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. Also Read: Lupin Gets USFDA Nod for Modafinil Tablets Used to Treat Excessive Sleepiness
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