USFDA19 Jul 2024, 04:15 pm
Caplin Point Subsidiary, Caplin Steriles, Receives USFDA Approval for Ephedrine Sulfate Injection
AI Summary
Caplin Steriles Limited, a subsidiary 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. This generic therapeutic equivalent version of the Reference Listed Drug (RLD) AKOVAZ from Exela Pharma Sciences LLC is indicated for the treatment of clinically important hypotension occurring in the setting of anaesthesia. According to IQVIA™, Ephedrine Sulfate injection USP 50 mg/mL had US sales of approximately $36 million for the 12-month period ending May 2024.
Key Highlights
- Caplin Steriles Limited receives USFDA approval for Ephedrine Sulfate injection USP, 50 mg/mL Single Dose vial
- The approved drug is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) AKOVAZ from Exela Pharma Sciences LLC
- The drug is indicated for the treatment of clinically important hypotension occurring in the setting of anaesthesia
- According to IQVIA™, 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 is a fast growing sterile product manufacturing company approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA