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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. ....

United States , Caplin Steriles , Drug Administration , Caplin Point Laboratories , United States Food , Abbreviated New Drug Application , Milrinone Lactate Injection , Capital Market , ஒன்றுபட்டது மாநிலங்களில் , கேப்ளின் பாயஂட் ஆய்வகங்கள் , ஒன்றுபட்டது மாநிலங்களில் உணவு , மூலதனம் சந்தை ,