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Hana Pharm Receives Approval of Byfavo 20mg in S. Korea
Date2021-08-31

- Fully-fledged Entry into the Endoscopy Market by Adding an indication for ‘Induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.’

- Application Expanded to Various Surgeries, with Byfavo 50mg (Induction and maintenance of General Anesthesia in Adults) launched in March


Hana Pharm (293480, Younha Lee, Ph.D., CEO) announced that Ministry of Food and Drug Safety (MFDS) has approved ‘Byfavo 20mg’ on August 30, 2021. Byfavo 50mg was approved for general anesthesia on January 2021, in S. Korea and as the indication for ‘Induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less’ was especially added to Byfavo 20mg.


Since the launch of Byfavo 50mg in this March, Hana Pharm has been successfully processing the substantial part of formulary uptake of Byfavo in top-tier university and tertiary hospitals. This additional approval of Byfavo 20mg is expected to be widely used in endoscopy-related sedation procedures and surgeries along with Byfavo 50mg.


“We are pleased to launch a new drug that overcomes the limitations of midazolam, which is widely used in procedural sedation, as well as propofol, with the additional indication for ‘Induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less’. This has expanded options for intravenous anesthesia and sedation according to the patient’s physical condition. Now that we have obtained both indications for anesthesia and procedural sedation, we will do our best to expand patient’s access to the new intravenous anesthetic named Byfavo.”, said Dr. Younha Lee, CEO of Hana Pharm. 


On the other hand, Byfavo has already been launched in the United States, China, and the United Kingdom for the indication of procedural sedation, and has also been received European Commission Approval on March.