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.

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.

Global pharma major Lupin announced on Friday that it received approval from the US health regulator for phytonadione injectable emulsion USP, which is used to treat low blood clotting and bleeding disorders resulting from vitamin K deficiency.

Lupin has received US FDA approval for its Phytonadione Injectable Emulsion prefilled syringe, used to treat hypoprothrombinemia and vitamin K-deficiency, which had estimated annual US sales of $52.3 million.

Lupin received US FDA approval for a vitamin K injection with a $52 million US market.