Overview
Tazarotene, commonly marketed as Tazorac®, Avage®, and Zorac®, is member of the acetylenic class of retinoids. It is a prodrug that is found in topical formulations used in the treatment of various conditons, such as psoriasis, acne, and sun damaged skin (photodamage).
Indication
Used to treat psoriasis, acne and sun damaged skin (photodamage).
Associated Conditions
- Psoriasis Vulgaris (Plaque Psoriasis)
- Benign facial lentigines
- Facial fine wrinkling
- Facial hyperpigmentation
- Facial hypopigmentation
- Mild Acne vulgaris
- Moderate Acne vulgaris
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/26 | Phase 2 | Recruiting | |||
2023/09/18 | Phase 4 | Completed | |||
2023/08/29 | Not Applicable | Completed | |||
2023/01/30 | Phase 4 | Completed | Dr. Emmy Graber | ||
2022/11/08 | Phase 3 | Active, not recruiting | |||
2022/10/10 | Phase 2 | Completed | |||
2022/09/27 | Phase 4 | Not yet recruiting | |||
2022/04/06 | Phase 2 | UNKNOWN | |||
2022/03/16 | Early Phase 1 | Completed | |||
2022/01/24 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mayne Pharma | 51862-295 | TOPICAL | 1 mg in 1 g | 2/28/2023 | |
| Mayne Pharma Inc. | 68308-685 | TOPICAL | 1 mg in 1 g | 1/1/2021 | |
| Allergan, Inc. | 0023-0042 | CUTANEOUS | 1 mg in 1 g | 11/20/2023 | |
| Cosette Pharmaceuticals, Inc. | 0713-0804 | TOPICAL | 1 mg in 1 g | 11/29/2023 | |
| Bausch Health US, LLC | 0187-0653 | TOPICAL | 0.45 mg in 1 g | 1/1/2020 | |
| Sincerus Florida, LLC | 72934-2093 | TOPICAL | 0.05 g in 100 g | 5/9/2019 | |
| Almirall, LLC | 16110-915 | CUTANEOUS | 0.05 mg in 1 g | 2/3/2020 | |
| Sincerus Florida, LLC | 72934-2161 | TOPICAL | 0.1 g in 100 g | 4/23/2019 | |
| Cosette Pharmaceuticals, Inc. | 0713-0805 | TOPICAL | 0.5 mg in 1 g | 11/29/2023 | |
| Sincerus Florida, LLC | 72934-2208 | TOPICAL | 0.05 g in 100 g | 7/2/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tazarotene Cream | 国药准字H20040124 | 化学药品 | 乳膏剂 | 8/23/2024 | |
| Tazarotene Gel | 国药准字H20010159 | 化学药品 | 凝胶剂 | 8/23/2024 | |
| Tazarotene Gel | 国药准字H20010726 | 化学药品 | 凝胶剂 | 8/23/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FABIOR tazarotene 0.1% w/w foam aerosol can | 364526 | Medicine | A | 11/2/2022 |
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