Caplin Steriles receives USFDA approval for Phytonadione Injectable Emulsion

Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) VITAMIN K1 Injection, from Hospira Inc.

Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K and is indicated for coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. According to IQVIATM (IMS Health), Phytonadione Injectable Emulsion had US sales of approximately $18.5 million for the 12-month period ending February 2025.

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