Caplin Point Gets USFDA Nod for Milrinone Injection

New Delhi, Sep 3 (PTI) Pharma firm Caplin Point Laboratories Ltd on Wednesday said its arm Caplin Steriles Ltd has received final approval from the US health regulator for its generic milrinone lactate in 5 per cent dextrose injection indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.

The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) milrinone lactate in 5 per cent Dextrose Injection of strengths 20 mg/100 mL and 40 mg/200 mL in single-dose infusion bags, Caplin Point Laboratories said in a regulatory filing.


The approved injection is a generic therapeutic equivalent version of the reference listed drug PRIMACOR in dextrose 5 per cent, by Sanofi Aventis US LLC, it added.

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, the company said.

Citing IQVIA (IMS Health) data, the company said milrinone lactate in 5 per cent dextrose injection had sales of approximately USD 11 million in the US for the 12-month period ended July 2025.