[ET Net News Agency, 14 January 2020] China Medical System Holdings Limited (00867)
said Neurelis announced that the U.S. FDA had approved its product VALTOCO (diazepam nasal
spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure
activity that are distinct from a patient's usual seizure pattern in people with epilepsy
6 years of age and older.
The group has been actively carrying out the regulatory application and other related
work of VALTOCO in China since Neurelis submitted the NDA to the U.S. FDA, and has
recently acquired the clinical trial notice of diazepam nasal spray from the National
Medical Products Administration of the People's Republic of China. The group is required
to conduct a comparative pharmacokinetic study in Chinese subjects, and to submit a
post-marketing study plan to further verify the efficacy and safety at the same time of
submitting the NDA. (RC)
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14/01/2020 13:50
CMS (00867): diazepam nasal spray gets approval from FDA
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