Chennai, JULY 19, 2024: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ephedrine Sulfate injection USP, 50 mg/mL Single Dose vial, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) AKOVAZ, from Exela Pharma Sciences LLC.
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension occurring in the setting of anaesthesia. According to IQVIATM (IMS Health), Ephedrine Sulfate injection USP 50 mg/mL had US sales of approximately $36 million for the 12-month period ending May 2024.