Gland Pharma receives USFDA approval for Phytonadione Injectable Emulsion

Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vitamin K1 Injectable Emulsion USP, 10 mg/mL, of Hospira, Inc.

This Product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.

The Company expects to launch this Product through its marketing partners in the near future. According to IQVIA, the product had US sales of approximately USD 15 million for the twelve months ending September 2024.

 

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