IMITREX STATDOSE (AUTOINJECTOR) (sumatriptan succinate) · GSK
IMITREX STATDOSE (AUTOINJECTOR) is FDA-approved to treat 1 condition (same as ONZETRA XSAIL).
Details
- Status
- Prescription
- First Approved
- 1992-12-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
IMITREX STATDOSE (AUTOINJECTOR) Approval History
What IMITREX STATDOSE (AUTOINJECTOR) Treats
1 indicationsIMITREX STATDOSE (AUTOINJECTOR) is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as ONZETRA XSAIL (same active ingredient).
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01381796 | PROT-15-NP101-013 | Ph 1 | completed | Compare PK and Bioavailability of 2 NP101 Patches With Oral Imitrex in Healthy Adults |
| NCT00723983 NP101-011 | PROT-15-NP101-011 | Ph 1 | completed | Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period |
| NCT00920686 results posted | NXN-188-203 | Ph 2 | completed | Study of NXN 188 for the Treatment of Migraine With Aura |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMITREX STATDOSE (AUTOINJECTOR) FDA Label Details
Indications & Usage
FDA Label (PDF)IMITREX STATDOSE (AUTOINJECTOR) is FDA-approved to treat 1 condition — same approved indications as ONZETRA XSAIL.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.