Caplin Steriles Limited on Wednesday announced that it 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.
According to the company’s statement, it is a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc.
Norepinephrine Bitartrate Injection is used for the restoration of blood pressure in adult patients with acute hypotensive states.
According to IQVIATM (IMS Health), Norepinephrine Bitartrate Injection USP had US sales of approximately $40 million for the 12-month period ending June 2023.
