Drug profile · INN
dexmedetomidine hydrochloride
PRECEDEX PARTIAL CHANGE APPROVAL
dexmedetomidine hydrochloride (PRECEDEX PARTIAL CHANGE APPROVAL) is a adrenergic receptor alpha-2 agonist. Associated with Regeneron Ireland Designated Activity Company (DAC). Route of administration: buccal, sublingual. Current US regulatory status: approved.
Drug details — dexmedetomidine hydrochloride
- US status
- approved
- Class
- —
- Route
- BUCCAL, SUBLINGUAL
- Patents
- 14
- Programs
- 33
- Data quality
- 0.89
Quick answer
dexmedetomidine hydrochloride (PRECEDEX PARTIAL CHANGE APPROVAL) is a adrenergic receptor alpha-2 agonist. Associated with Regeneron Ireland Designated Activity Company (DAC). Route of administration: buccal, sublingual. Current US regulatory status: approved.
Key facts
Mechanism of action
Adrenergic receptor alpha-2 agonist
Primary target: Adrenergic receptor alpha-2
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| PMDA | approved | — |
Pipeline programs
Related & competitor drugs
-
US 12364683
Non-sedating dexmedetomidine treatment regimens
granted -
US 12138247
Non-sedating dexmedetomidine treatment regimens
granted -
US 12109196
Non-sedating dexmedetomidine treatment regimens
granted -
US 12090140
Non-sedating dexmedetomidine treatment regimens
granted -
US 11998529
Non-sedating dexmedetomidine treatment regimens
granted -
US 11998528
Non-sedating dexmedetomidine treatment regimens
granted -
US 11890272
Non-sedating dexmedetomidine treatment regimens
granted -
US 11839604
Use of sublingual dexmedetomidine for the treatment of agitation
granted -
US 11806334
Non-sedating dexmedetomidine treatment regimens
granted -
US 11786508
Use of sublingual dexmedetomidine for the treatment of agitation
granted -
US 11517524
Film formulations containing dexmedetomidine and methods of producing them
granted -
US 11497711
Film formulations containing dexmedetomidine and methods of producing them
granted -
US 11478422
Film formulations containing dexmedetomidine and methods of producing them
granted -
US 10792246
Film formulations containing dexmedetomidine and methods of producing them
granted
Frequently asked questions
What is dexmedetomidine hydrochloride?
dexmedetomidine hydrochloride (PRECEDEX PARTIAL CHANGE APPROVAL) is a adrenergic receptor alpha-2 agonist. Associated with Regeneron Ireland Designated Activity Company (DAC). Route of administration: buccal, sublingual. Current US regulatory status: approved.
What is the brand name for dexmedetomidine hydrochloride?
PRECEDEX PARTIAL CHANGE APPROVAL is a marketed brand name for dexmedetomidine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of dexmedetomidine hydrochloride?
dexmedetomidine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.