India, April 23 -- Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 10 mg/mL in a single-dose vial.
This product is the generic equivalent of Hospira Inc.'s Vitamin K1 Injection, a Reference Listed Drug (RLD). Phytonadione, a synthetic form of vitamin K, is used to treat coagulation disorders caused by a deficiency or disruption in the activity of vitamin K, which is essential for the formation of clotting factors II, VII, IX, and X.
According to IQVIA™ data, sales of Phytonadione Injectable Emulsion in the U.S. reached approximatel...