Caplin Point Laboratories Ltd on Wednesday said its subsidiary, Caplin Steriles Ltd, has received final approval from the US Food and Drug Administration (USFDA) for its generic milrinone lactate in 5% dextrose injection. The drug is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.
The approval covers abbreviated new drug applications (ANDA) for 20 mg/100 mL and 40 mg/200 mL strengths in single-dose infusion bags. The product is the therapeutic equivalent of Sanofi Aventis US LLC’s reference listed drug PRIMACOR in 5% dextrose.