Seysara is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of use include that efficacy beyond 12 weeks and safety beyond 12 months have not been established. Additionally, Seysara has not been evaluated for the treatment of infections. To maintain the effectiveness of antibacterial drugs and reduce the development of drug-resistant bacteria, Seysara should be used only as indicated.
How SEYSARA Works
Sarecycline is an aminomethylcycline within the tetracycline class of drugs. The specific mechanism of action of Seysara in treating the inflammatory lesions of non-nodular acne vulgaris is not known.
Details
- Status
- Prescription
- First Approved
- 2018-10-01
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
SEYSARA Approval History
What SEYSARA Treats
1 indicationsSEYSARA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
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Trial Timeline
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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.
SEYSARA FDA Label Details
Indications & Usage
FDA Label (PDF)SEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ] . SEYSARA ® is a tetracycline-cl...
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Deep insights for SEYSARA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 45 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.