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Valtoco Approval Status

FDA Approved: No
Brand name: Valtoco
Generic name: diazepam
Dosage form: Nasal Spray
Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is an investigational benzodiazepine nasal spray formulation in development for the treatment of epilepsy cluster seizures.

Development Status and FDA Approval Process for Valtoco

DateArticle
Sep 25, 2018Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
Jan  4, 2017Neurelis Intranasal Diazepam Treatment For Epilepsy Granted Fast Track Designation By FDA
May 20, 2016Acorda to Discontinue Development of Plumiaz (diazepam nasal spray) for Treatment of Epilepsy Seizure Clusters
May  2, 2014FDA Issues Complete Response Letter for Plumiaz (diazepam nasal spray) for Epilepsy Cluster Seizures
Mar 20, 2013Diazepam Nasal Spray Demonstrates Comparable Bioavailability to Diazepam Rectal Gel in Pharmacokinetic Study
Jun 22, 2011Particle Sciences Develops Proprietary Nasal Delivery Formulation Used in Neurelis' Recently Announced Successful Phase I Pharmacokinetic Study of NRL-01 (intranasal diazepam)

Further information

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