Home / Health / Lupin Gets USFDA Nod for Clotting Disorder Drug
Lupin Gets USFDA Nod for Clotting Disorder Drug
9 Oct
Summary
- Lupin received USFDA approval for phytonadione injectable emulsion.
- The drug treats bleeding disorders from vitamin K deficiency.
- The US market for this drug was valued at $52.3 million annually.
Pharma major Lupin announced on Friday that it has received approval from the US health regulator for its phytonadione injectable emulsion USP. This medication is used to treat low blood clotting and bleeding disorders stemming from vitamin K deficiency.
The United States Food and Drug Administration (USFDA) has approved Lupin's phytonadione injectable emulsion USP, specifically the 1 mg/0.5 mL single-dose prefilled syringe. This formulation has been confirmed as bioequivalent to the reference listed drug.
According to market data from August 2026, Lupin's Abbreviated New Drug Application (ANDA) for this emulsion indicated substantial market potential. The estimated annual sales in the US for phytonadione injectable emulsion reached $52.3 million, highlighting its importance in treating hypoprothrombinemia and vitamin K deficiency.
