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Recently, the official website of the State Food and Drug Administration showed that the entacapone tablets declared by Dongyang Sunshine according to registration classification 4 have been approved for marketing by NMPA (approval number: National Medicine Standard H20213207).
Entacapone was developed by Orion Pharma and was first approved for marketing in Europe in 1998.
Entacapone is a reversible and specific peripheral catechol O-methyltransferase (COMT) inhibitor, which reduces the metabolism of levodopa to 3-O-methyldopa (3-OMD) by inhibiting the COMT enzyme , Thereby increasing the bioavailability of levodopa, increasing the total amount of levodopa available in the brain, prolonging its clinical effect, and helping patients achieve motor symptom control.
In November 2018, the entacapone film produced by Dongyang Sunshine was produced in the same production line according to the priority review scope (1).
In addition to Dongyang Sunshine's approval of the product, Hainan General Kangli Pharmaceutical will also apply for production in February 2020 according to category 4 after completing the BE study.
Fosun Pharma’s application for the same target drug Opicapone Capsules introduced from Ongentys was also accepted by the CDE on March 10.
