Flumazenil

Sold as Romazicon. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 15, 2026, FDA lists 10 applications for Flumazenil (sold as Romazicon), first approved Dec 20, 1991, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 20, 1991
Applications: 10
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $46K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Flumazenil	Part D	$46K	-12%	4,546

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FLUMAZENIL 0.5 MG/5 ML VIAL: $1.18 per MLGeneric · +19% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

treatment of idiopathic hypersomniaAntriva Therapeutics Corporation · designated Oct 31, 2026

Clinical Trials

11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Remimazolam Concentration and Sedation Depth During Lower Extremity Surgery Under Spinal AnesthesiaSedation During Lower Extremity Surgery Under Spinal Anesthesia · Seoul National University Hospital	Phase 4	Not yet recruiting	Oct 7, 2026
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic RepairAortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal · Seoul National University Hospital	Phase 4	Recruiting	Sep 8, 2026
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous PressureIntraoperative Hypotension, Hepatectomy · Beijing Tsinghua Chang Gung Hospital	Phase 4	Recruiting	Aug 27, 2026
Remimazolam Versus Propofol for Early Recovery After Cytoreductive SurgeryPeritoneal Neoplasms, Postoperative Recovery · Beijing Tsinghua Chang Gung Hospital	Not applicable	Not yet recruiting	Aug 25, 2026
Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day SurgeryHysteroscopy, Ambulatory Surgery · Chung-Ang University Gwangmyeong Hospital	Phase 4	Not yet recruiting	Jun 23, 2026
Flumazenil for Benzodiazepine Reversal in Electroconvulsive TherapyDepression - Major Depressive Disorder, Bipolar Disorder (BD) · Anders Jørgensen	Not applicable	Recruiting	Jun 1, 2026
Cardiologist-Administered Midazolam vs. Anaesthesiologist-Assisted Propofol Sedation For Transoesophageal Echocardiography-Guided Cardioversion of Atrial FibrillationAtrial Fibrillation (AF), Atrial Flutter · Gødstrup Hospital	Phase 4	Not yet recruiting	May 6, 2026
The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal AnesthesiaPostoperative Delirium, Sedation · Medical University of Gdansk	Phase 4	Not yet recruiting	Dec 11, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 20, 1991	RomaziconNDA 20073 · New molecular entity	Hoffmann La Roche	14	Discontinued
Oct 12, 2004	FlumazenilANDA 76256	Hikma	1	Marketed
Oct 12, 2004	FlumazenilANDA 76589	Dr Reddys	0	Discontinued
Oct 12, 2004	FlumazenilANDA 76755	Baxter Hlthcare Corp	1	Marketed
Oct 12, 2004	FlumazenilANDA 76787	Hikma	1	Discontinued
Oct 12, 2004	FlumazenilANDA 76955	Fresenius Kabi USA	0	Marketed
May 3, 2005	FlumazenilANDA 77071	Sandoz	1	Marketed
May 13, 2008	FlumazenilANDA 78595	Rising	0	Marketed
Mar 23, 2009	FlumazenilANDA 78527	Hikma Farmaceutica	0	Marketed
Aug 28, 2012	FlumazenilANDA 90584	Sagent Pharms	1	Marketed

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