U.S.-based Cosmo Pharmaceutical has submitted a new drug application (NDA) for Remimazolam, a sedative developed by Germany’s Paion, to the Food and Drug Administration, Hana Pharmaceutical said Tuesday.
Hana also licensed in Remimazolam from Paion and completed local phase 3 clinical in October last year, while Mundipharma, Paion’s partner in Japan, submitted its NDA in Japan in December.
Remimazolam, like Propofol, enables rapid induction and maintenance of general anesthesia, and has applications as an antidote without inducing respiratory depression or vigor symptom instability like Midazolam.
Hana expects Remimazolam will replace the anesthetic market quickly and reliably, supplementing the shortcomings of existing intravenous anesthetics.
“We, too, are planning to apply for Remimazolam’s NDA by the end of this year to launch the drug in the second half of 2020,” a Hana official said. “To prepare for the domestic launch and export of Remimazolam, we are building certified injection facilities that can meet European and Japanese good manufacturing practice (GMP), in Hwaseong, Gyeonggi province."
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