AVAGE (tazarotene) · ALMIRALL
Tazarotene (marketed as Tazorac for these indications) is a topical retinoid cream used for the treatment of plaque psoriasis and acne vulgaris. Both the 0.05% and 0.1% concentrations are indicated for the management of plaque psoriasis, while the 0.1% strength is also indicated for the treatment of acne vulgaris. (Note: The brand name *Avage* is specifically indicated for photoaging rather than the conditions listed here).
How AVAGE Works
Tazarotene is a retinoid prodrug that is converted to its active form, tazarotenic acid, through deesterification after application. It binds to all three members of the retinoic acid receptor (RAR) family (RARα, RARβ, and RARɣ) but shows relative selectivity for RARβ and RARɣ. This binding may modify gene expression; however, the clinical significance of these specific receptor interactions is unknown.
Details
- Status
- Prescription
- First Approved
- 2000-09-29
- Routes
- TOPICAL
- Dosage Forms
- CREAM
AVAGE Approval History
What AVAGE Treats
2 indicationsAVAGE is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
AVAGE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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.
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ALMIRALL's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01019603 | 114565 | Ph 1 | completed | A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris |
| NCT00834210 results posted | MA-ACZ0802 | Ph 4 | completed | Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris |
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.
AVAGE FDA Label Details
Indications & Usage
FDA Label (PDF)TAZORAC ® Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. 1.1 Plaque Psoriasis TAZORAC ® (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.