Overview
Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.
Background
Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.
Indication
Used as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum.
Associated Conditions
- Fungal skin infection
- Pityriasis versicolor
- Seborrheic dermatitis of the scalp
- Tinea Corporis
- Tinea Cruris
- Tinea Pedis
- Vulvovaginal Candidiasis
- Cutaneous candidiasis
- Mild Onychomycosis
- Moderate Onychomycosis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/12/05 | Phase 3 | Completed | |||
2006/09/29 | Not Applicable | Withdrawn |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cosette Pharmaceuticals, Inc. | 0713-0317 | TOPICAL | 80 mg in 1 mL | 5/2/2022 | |
| Bryant Ranch Prepack | 63629-8622 | TOPICAL | 7.7 mg in 1 g | 2/22/2022 | |
| Bryant Ranch Prepack | 72162-1126 | TOPICAL | 7.7 mg in 1 g | 3/11/2024 | |
| Acella Pharmaceuticals, LLC | 42192-715 | TOPICAL | 80 mg in 1 mL | 10/23/2019 | |
| VersaPharm Incorporated | 61748-200 | TOPICAL | 80 mg in 1 mL | 11/12/2014 | |
| Rebel Distributors Corp. | 21695-475 | TOPICAL | 71.3 mg in 1 mL | 10/9/2009 | |
| E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0407 | TOPICAL | 7.70 mg in 1 g | 10/15/2013 | |
| Innocutis Holdings LLC | 68712-027 | TOPICAL | 2.28 g in 1 mL | 12/1/2011 | |
| Physicians Total Care, Inc. | 54868-6064 | TOPICAL | 80 mg in 1 mL | 5/19/2010 | |
| Bryant Ranch Prepack | 72162-1321 | TOPICAL | 80 mg in 1 mL | 3/21/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||