EVOXAC (cevimeline hydrochloride)
EVOXAC is indicated for the treatment of Dry Mouth; Sjögren's Syndrome.
Details
- Status
- Prescription
- First Approved
- 2000-01-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE
EVOXAC Approval History
What EVOXAC Treats
2 indicationsEVOXAC is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dry Mouth
- Sjögren's Syndrome
EVOXAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in EVOXAC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications EVOXAC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to EVOXAC
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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.
EVOXAC FDA Label Details
Indications & Usage
FDA Label (PDF)EVOXAC is indicated for the treatment of Dry Mouth; Sjögren's Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.