Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

By: IPP Bureau

Last updated : July 23, 2024 1:43 pm



Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension


Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, 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.

Caplin Steriles Limited USFDA Caplin Point Laboratories Limited

First Published : July 23, 2024 12:00 am