USFDA3 Sept 2025, 02:06 pm
Caplin Point's Subsidiary Receives USFDA Approval for Milrinone Lactate in 5% Dextrose Injection
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its ANDA Milrinone Lactate in 5% Dextrose Injection. This product is a generic therapeutic equivalent version of the RLD PRIMACOR in Dextrose 5% by Sanofi Aventis US LLC. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. According to IQVIA™, Milrinone Lactate in 5% Dextrose Injection had US sales of approximately $11 million for the 12-month period ending July 2025.
Key Highlights
- Caplin Steriles Limited received USFDA approval for Milrinone Lactate in 5% Dextrose Injection
- The product is a generic therapeutic equivalent version of the RLD PRIMACOR in Dextrose 5% by Sanofi Aventis US LLC
- Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
- According to IQVIA™, Milrinone Lactate in 5% Dextrose Injection had US sales of approximately $11 million for the 12-month period ending July 2025