Application Nr Approved Date Route Status External Links
NDA206099 None Nasal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Onzetra ® Xsail ® Is Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults. Onzetra Xsail Is A Serotonin 5-Ht 1b/1d Receptor Agonist (Triptan) Indicated For The Acute Treatment Of Migraine With Or Without Aura In Adults ( 1 ). Limitations Of Use Use Only If A Clear Diagnosis Of Migraine Headache Has Been Established ( 1 ) Not Indicated For The Prophylactic Therapy Of Migraine Attacks ( 1 ) Not Indicated For The Treatment Of Cluster Headache ( 1 ) Limitations Of Use Use Only If A Clear Diagnosis Of Migraine Has Been Established. If A Patient Has No Response To The First Migraine Attack Treated With Onzetra Xsail, Reconsider The Diagnosis Of Migraine Before Treatment Of Subsequent Attacks With Onzetra Xsail. Onzetra Xsail Is Not Indicated For The Prevention Of Migraine Attacks. Safety And Effectiveness Of Onzetra Xsail Have Not Been Established For The Treatment Of Cluster Headache.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sumatriptan Succinate SUMATRIPTAN SUCCINATE ZINC14360

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