Tavaborole 43.5 mg/mL
Tavaborole · SOLUTION · Zydus Lifesciences Limited
Tavaborole is a solution containing tavaborole at 43.5 mg/mL, taken topical. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Tavaborole
- Generic Name
- Tavaborole
- NDC Code (Product)
70771-1826- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 43.5 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA212294
- Drug Class
- Oxaborole Antifungal [EPC]
- Marketing Start
- 04/24/2023
Recall History
VIONA PHARMACEUTICALS INC
Discoloration
VIONA PHARMACEUTICALS INC
Discoloration
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes . (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply tavaborole topical solution to affected toenails once daily for 48 weeks. Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. Tavaborole topical solution is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply tavaborole topical solution to affected toenails once daily for 48 weeks. (2) • Tavaborole topical solution should be applied to the entire toenail surface and under the tip of each toenail being treated. (2) • For topical use only. (2) • Not for oral, ophthalmic, or intravaginal use. (2)
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Adverse Reactions
6 ADVERSE REACTIONS Common adverse reactions occurring in ≥1% in subjects treated with tavaborole topical solution included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two clinical trials, 791 subjects were treated with Tavaborole topical solution. The most commonly reported adverse reactions are listed below (Table 1). Table 1 : Adverse Reactions Occurring in ≥1% of Tavaborole topical solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle Preferred Term Tavaborole topical solution N= 791 n(%) Vehicle N= 395 n(%) Application site exfoliation 21 (2.7%) 1 (0.3%) Ingrown toenail 20 (2.5%) 1 (0.3%) Application site erythema 13 (1.6%) 0 (0%) Application…
Frequently Asked Questions
What is Tavaborole used for?
Tavaborole contains Tavaborole. It is a solution taken topical. Consult your doctor for specific uses.
Is Tavaborole a controlled substance?
Tavaborole is not classified as a controlled substance by the DEA.
What is the generic name for Tavaborole?
The generic name for Tavaborole is Tavaborole. There are 2 other brand versions of Tavaborole.
What is the NDC code for Tavaborole 43.5 mg/mL?
The NDC (National Drug Code) for Tavaborole 43.5 mg/mL is 70771-1826, listed by Zydus Lifesciences Limited.