Caplin Steriles Receives USFDA Approval for Milrinone Lactate
Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories, has secured USFDA approval for its generic milrinone lactate injection. The US health regulator approved the injection for short-term treatment of acute heart failure. The approved drug is a generic version of Sanofi Aventis's PRIMACOR.
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Pharma firm Caplin Point Laboratories Ltd announced that its subsidiary Caplin Steriles Ltd received final approval from the US Food and Drug Administration (USFDA) for its generic version of milrinone lactate in 5 per cent dextrose injection. This medication is indicated for short-term intravenous treatment of acute decompensated heart failure.
The USFDA approved Caplin Steriles's abbreviated new drug application (ANDA) for milrinone lactate in 5 per cent Dextrose Injection in strengths of 20 mg/100 mL and 40 mg/200 mL, available in single-dose infusion bags. This approval marks a significant milestone for the company as it expands its portfolio in the US market.
Caplin Point Laboratories revealed that the generic injection is therapeutically equivalent to Sanofi Aventis's PRIMACOR in dextrose 5 per cent. According to IQVIA data, milrinone lactate in 5 per cent dextrose injection garnered approximately USD 11 million in US sales over the past year.
(With inputs from agencies.)
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