Caplin Steriles gets USFDA approval for Norepinephrine Bitartrate Injection

Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial, a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc.

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states. According to IQVIA (IMS Health), Norepinephrine Bitartrate Injection USP had US sales of approximately $40 million for the 12-month period ending June 2023.