Sugammadex Sodium

Sold as Bridion. Every FDA application for this active ingredient: 1 branded and 20 generic.

As of Nov 15, 2026, FDA lists 21 applications for Sugammadex Sodium (sold as Bridion), first approved Dec 15, 2015, with 4 new uses approved and 0 published complete response letters.

First approved: Dec 15, 2015
Applications: 21
New uses approved: 4
Complete response letters: 0
First approved in the EU: Jul 25, 2008
First approved in Japan: Jan 20, 2010

Approvals in the EU (EMA)

First approved in the EU 89 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Sugammadex Piramal, genericPiramal Critical Care B.V. · Jun 23, 2023
Sugammadex AdroiqExtrovis EU Ltd · May 26, 2023
Sugammadex Amomed, genericAOP Orphan Pharmaceuticals GmbH · Jan 10, 2023
Sugammadex Fresenius Kabi, genericFresenius Kabi Deutschland GmbH · Jul 15, 2022
Sugammadex Mylan, genericMylan Pharmaceuticals Limited · Nov 15, 2021
Bridion, new substanceMerck Sharp & Dohme B.V. · Jul 25, 2008

Approvals in Japan (PMDA)

First approved in Japan 71 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Bridion, new ingredientDrugs with a new active ingredient indicated for the recovery from neuromuscular blockade induced by rocuronium bromide or vecuronium bromide. · Schering-Plough K.K. · Jan 20, 2010 · Review report

Clinical Trials

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


Comparison of NMTCuff and Standard TOF in Gynecologic Oncology Surgery (NMTCUFF-TOF)Gynecologic Cancer, Neuromuscular Blockade · Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital	—	Recruiting	Nov 9, 2026
Sugammadex Timing and Recovery Profile in Pediatric AdenotonsillectomyNeuromuscular Blockade, Delayed Emergence From Anesthesia · Namik Kemal University	—	Not yet recruiting	Oct 28, 2026
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway InsertionAirway Management, Supraglottic Airway Device Insertion · Hacettepe University	Phase 4	Not yet recruiting	Oct 26, 2026
REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential MonitoringAirway Management, Endotracheal Intubation · Mayo Clinic	Phase 4	Not yet recruiting	Sep 22, 2026
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac SurgeryMinimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery · Dr. Nguyen Thi Thu Hang	—	Recruiting	Sep 1, 2026
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES HysterectomyLeiomyoma, Uterine, Benign Gynecological Disease · Fatih Sultan Mehmet Training and Research Hospital	Not applicable	Recruiting	Jul 28, 2026
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal TransplantationKidney Disease, End-Stage, Kidney Transplant · University of Gaziantep	Not applicable	Recruiting	Jul 1, 2026
Fentanyl and Rocuronium for Tracheal Intubation in NewbornsInfant, Premature, Intubation, Intratracheal · UEA - Universidade Do Estado Do Amazonas	Phase 4	Not yet recruiting	Jun 16, 2026

Applications

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


Dec 15, 2015	BridionNDA 22225 · New molecular entity	Msd Sub Merck	7	Marketed
Jun 9, 2023	Sugammadex SodiumANDA 214337	Aspiro	1	Marketed
Oct 4, 2023	Sugammadex SodiumANDA 214290	Zydus Pharms	1	Marketed
Aug 5, 2025	Sugammadex SodiumANDA 214279	B Braun Medical	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 213915	Mylan	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214126	Teva Pharms USA Inc	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214230	Mankind Pharma	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214236	Dr Reddys	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214306	Zenara	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214311	Sandoz	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214319	Sun Pharm Inds Inc	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214338	Lupin	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214364	Gland	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 214368	Msn	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 215260	Tamarang	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 215575	Qilu Pharm Hainan	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 218727	Hikma	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 218728	Hikma	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 218814	Steriscience	0	Marketed
Jul 28, 2026	Sugammadex SodiumANDA 219448	Fresenius Kabi USA	0	Marketed
Oct 6, 2026	Sugammadex SodiumANDA 215701	Shandong	0	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