Indian pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe.
The product has been approved as bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems Limited.
Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.
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