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Nayzilam FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 29, 2019.

FDA Approved: Yes (First approved May 17, 2019)
Brand name: Nayzilam
Generic name: midazolam
Dosage form: Nasal Spray
Company: UCB, Inc.
Treatment for: Seizure Clusters

Nayzilam (midazolam) is a nasally administered benzodiazepine indicated for the acute treatment of seizure clusters.

Development timeline for Nayzilam

May 20, 2019Approval FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters
Aug 13, 2018FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters

Further information

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