Hana Pharm Receives Market Approval for Byfavo (Remimazolam) in Procedural Sedation in South Korea
August 31, 2021 at 03:32 am EDT
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The Specialty Pharma Company PAION AG announces that Hana Pharm Co., Ltd. remimazolam licensee for South Korea, informed PAION that South Korea's Ministry of Food and Drug Safety has approved 'Byfavo 20mg' on 30 August 2021 for the indication "Induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less" as well as for the indication "induction and maintenance of general anesthesia in adults". 'Byfavo 50mg' was already approved for the latter indication in January 2021. This additional approval of 'Byfavo 20mg' is expected to be widely used in endoscopy-related sedation procedures and surgeries. This additional approval of 'Byfavo 20mg' is expected to be widely used in endoscopy-related sedation procedures and surgeries. PAION granted Hana Pharm the exclusive rights to develop and commercialize Byfavo for the South Korean market in 2013. Under the terms of the agreement, PAION is entitled to receive 10% royalties on Hana Pharm's remimazolam revenues in South Korea.
HANA PHARM CO., LTD is a Korea-based company mainly engaged in the manufacturing and distribution of specialty pharmaceuticals. The companyâs main products include cardiovascular drugs involves hypertension and hyperlipidemia medicines, as well as blood circulation improvement drugs; analgesics for severe pain and anesthetics for surgery and sedation; as well as gastrointestinal drugs such as peptic ulcer treatment and antispasmodics. The Company also provides antibiotics, dermatology analgesics, antipyretics and anti-inflammatory drugs.