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Treats intermittent, stereotypic episodes of frequent seizure activity. Sold as Nayzilam, Midazolam In 0.9% Sodium Chloride, Midazolam In 0.8% Sodium Chloride. Every FDA application for this active ingredient: 3 branded and 4 generic.
As of Nov 13, 2026, FDA lists 7 applications for Midazolam (sold as Nayzilam, Midazolam In 0.9% Sodium Chloride, Midazolam In 0.8% Sodium Chloride), first approved May 17, 2019, with 0 new uses approved and 1 published complete response letter.
First approved: May 17, 2019
Applications: 7
New uses approved: 0
Complete response letters: 1
Medicare spending, 2025: $46.3M
Shortage: Current
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Dormicum, new approvalA drug with a new route of administration indicated for anesthetic premedication. · Maruishi Pharmaceutical Co., Ltd. · Sep 19, 2025
MidafresaA drug with a new dosage indicated for the treatment of status epilepticus. · Alfresa Pharma Corporation · Sep 27, 2021
Buccolam Oromucosal, new approvalDrugs with a new route of administration indicated for the treatment of status epilepticus. · · Sep 25, 2020
Midafresa, new approvalA drug with a new additional indication and a new dosage in an additional dosage form indicated for the treatment of status epilepticus. · Alfresa Pharma Corporation · Sep 26, 2014
DormicumA drug with a new additional indication and a new dosage for sedation during surgeries and other procedures in the field of dentistry and oral surgery. · Astellas Pharma Inc. · Dec 20, 2013
DormicumA drug with a new additional pediatric dosage indicated for anesthetic premedication and for sedation during artificial respiration in patients under… · Astellas Pharma Inc. · Mar 12, 2010
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
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