Application Nr Approved Date Route Status External Links
NDA209128 None Sublingual None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dsuvia Is Indicated For Use In Adults In A Certified Medically Supervised Healthcare Setting, Such As Hospitals, Surgical Centers, And Emergency Departments, For The Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Limitations Of Use: • Not For Home Use Or For Use In Children. Discontinue Treatment With Dsuvia Before Patients Leave The Certified Medically Supervised Healthcare Setting. • Not For Use For More Than 72 Hours. The Use Of Dsuvia Beyond 72 Hours Has Not Been Studied. • Only To Be Administered By A Healthcare Provider. • Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [See Warnings And Precautions ( 5.4 ) ], Reserve Dsuvia For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products]: - Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, - Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia. Dsuvia Contains Sufentanil, An Opioid Agonist, And Is Indicated For Use In Adults In A Certified Medically Supervised Healthcare Setting, Such As Hospitals, Surgical Centers, And Emergency Departments, For The Management Of Acute Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Limitations Of Use • Not For Home Use Or For Use In Children. Discontinue Treatment With Dsuvia Before Patients Leave The Certified Medically Supervised Healthcare Setting. • Not For Use For More Than 72 Hours. • Only To Be Administered By A Healthcare Provider. • Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Dsuvia For Use In Patients For Whom Alternative Treatment Options [E.g., Non-Opioid Analgesics Or Opioid Combination Products]: - Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, - Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sufentanil SUFENTANIL ZINC538386

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