Drug firm Caplin Point Laboratories on Monday said its arm Caplin Steriles has received final nod from the US health regulator for generic Milrinone Lactate injection, used for short-term intravenous treatment of patients with acute decompensated heart failure.
Caplin Steriles has been granted "final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Milrinone Lactate Injection USP, 10 mg/10 mL (1 mg/mL), 20 mg/20 mL (1 mg/mL), 50 mg/50 mL (1 mg/mL), single-dose vial presentation...," Caplin Point Laboratories said in a filing to BSE.
The product is a generic version of Sanofi-Aventis U.S. LLC's, Primacor injection in the strength of 1 mg/mL, it added.
According to IQVIA data, Milrinone Lactate injection had US sales of around USD 24 million for the 12-month period ending Dec 2020, for both the vial and bag presentations, the filing said.
The product is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, it added.
Shares of Caplin Point Laboratories were trading at Rs 494.30 per scrip on BSE, up 6.03 percent from its previous close.