Heart failure treatment: USFDA approves Caplin Steriles Milrinone Lactate in 5% Dextrose Injection, Infusion bags
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags.
The product is a generic therapeutic equivalent version of the Reference Listed Drug (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 (IMS Health), Milrinone Lactate in 5% Dextrose Injection had US sales of approximately $11 million for the 12-month period ending July 2025.
Read also: Caplin Steriles gets USFDA nod for Eye Drop for reduction of elevated intraocular pressure
Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited has developed and filed 51 ANDAs (including two ANDA’s acquired in the month of April 2025) in USA on its own and with partners, with 40 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, Saudi Arabia etc.
