India, Oct. 8 -- Lupin Limited (LUPIN) said the U.S. FDA has approved its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe, adding another product to the company's U.S. injectable medicines portfolio.
Phytonadione, commonly known as vitamin K1, is used to treat and prevent hypoprothrombinemia, a condition in which the blood does not clot properly, as well as vitamin K deficiency. These conditions can increase the risk of excessive bleeding and may occur due to certain medical conditions or medications.
The FDA approved Lupin's product through the Abbreviated New Drug Application (ANDA) pathway. According to the company, the product has been found to be a bioequivalent to the reference listed drug, Phytonadio...