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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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