Adasuve

Product manufactured by Galen Us Incorporated

Application Nr Approved Date Route Status External Links
NDA022549 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Adasuve Is A Typical Antipsychotic Indicated For The Acute Treatment Of Agitation Associated With Schizophrenia Or Bipolar I Disorder In Adults. “psychomotor Agitation” Is Defined In Dsm-Iv As “excessive Motor Activity Associated With A Feeling Of Inner Tension.” Patients Experiencing Agitation Often Manifest Behaviors That Interfere With Their Care (E.g., Threatening Behaviors, Escalating Or Urgently Distressing Behavior, Self-Exhausting Behavior), Leading Clinicians To The Use Of Rapidly Absorbed Antipsychotic Medications To Achieve Immediate Control Of The Agitation [ See Clinical Studies ( 14 ) ] . The Efficacy Of Adasuve Was Established In One Study Of Acute Agitation In Patients With Schizophrenia And One Study Of Acute Agitation In Patients With Bipolar I Disorder [ See Clinical Studies ( 14 ) ] . Limitations Of Use: As Part Of The Adasuve Rems Program To Mitigate The Risk Of Bronchospasm, Adasuve Must Be Administered Only In An Enrolled Healthcare Facility [ See Warnings And Precautions ( 5.2 ) ] . Adasuve Is A Typical Antipsychotic Indicated For The Acute Treatment Of Agitation Associated With Schizophrenia Or Bipolar I Disorder In Adults. Efficacy Was Demonstrated In 2 Trials In Acute Agitation: One In Schizophrenia And One In Bipolar I Disorder ( 1 , 14 ) Limitations Of Use: Adasuve Must Be Administered Only In An Enrolled Healthcare Facility ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Loxapine LOXAPINE ZINC19796158

Comments