USFDA23 Apr 2025, 04:15 pm
Caplin Point's Subsidiary Caplin Steriles Receives USFDA Approval for Phytonadione Injectable Emulsion
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its ANDA Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial. This is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) VITAMIN K1 Injection, from Hospira Inc. The drug is indicated for coagulation disorders which are due to faulty formation of factors Il, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. As per IQVIA™, Phytonadione Injectable Emulsion had US sales of approximately $18.5 million for the 12-month period ending February 2025.
Key Highlights
- Caplin Steriles Limited received USFDA approval for Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial.
- The approved drug is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) VITAMIN K1 Injection, from Hospira Inc.
- Phytonadione Injectable Emulsion is indicated for coagulation disorders which are due to faulty formation of factors Il, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.
- As per IQVIA™, Phytonadione Injectable Emulsion had US sales of approximately $18.5 million for the 12-month period ending February 2025.