ADAPALENE
Details
- Status
- Prescription
- First Approved
- 2010-06-02
- Routes
- TOPICAL
- Dosage Forms
- SOLUTION, GEL, CREAM
Companies
ADAPALENE Approval History
What ADAPALENE Treats
10 FDA approvalsOriginally approved for its first indication in 2010 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Jun 2010)Letter
- • Approved indication (Jun 2010)Letter
- • Approved indication (Jul 2010)
- • Approved indication (Jun 2012)
- • Approved indication (Oct 2014)Letter
- • Approved indication (Jan 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Jun 2020)
- • Approved indication (Jan 2022)
ADAPALENE Competitors
Pro4 other drugs also target Retinoic acid receptor. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (Retinoic acid receptor). Earlier expiry dates signal biosimilar/generic opportunities.
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.
ADAPALENE FDA Label Details
ProIndications & Usage
Use For the treatment of acne
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.