Lupin Gets U.S. FDA Approval for Phytonadione Injectable Emulsion
Mumbai, Oct 9 (TNT): Global pharmaceutical major Lupin Limited on Friday said it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, in a single-dose prefilled syringe.
The product has been approved as bioequivalent to the reference listed drug manufactured by International Medication Systems Limited, the Mumbai based Pharma company said in a release here.
It is indicated for the treatment and prevention of hypoprothrombinemia, a condition associated with reduced blood clotting, and vitamin K deficiency.
According to IQVIA data for the 12 months ended August 2026, the product recorded estimated annual sales of USD 52.3 million in the United States.
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