[ET Net News Agency, 27 September 2018] China Medical System (00867) said Neurelis t
has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA)
for VALTOCO (diazepam nasal spray) as a treatment for epilepsy patients six years and
older who experience bouts of increased seizure activity, also known as acute repetitive
or cluster seizures.
Earlier this year, FDA provided conditional acceptance for use of the name "VALTOCO" for
the product previously referred to in clinical development as "NRL-1".
The group will prepare for the regulatory application and other related work of VALTOCO
in China after Neurelis submits the NDA with FDA for it. (SC)
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27/09/2018 09:51
CMS (00867) submits application for new epilepsy drug
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