Caplin Steriles receives final USFDA approval for Milrinone Lactate Injection

Caplin Steriles (Caplin), a subsidiary company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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, a generic therapeutic equivalent version of (RLD), PRIMACOR Injection, 1 mg/mL, of Sanofi-Aventis U.S. LLC.

Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. According to IQVIATM (IMS Health), Milrinone Lactate Injection had US sales data of approximately $24 million for the 12-month period ending Dec 2020, for both the Vial and Bag presentations, the latter of which is under development at Caplin Steriles.

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