September 2025: Madrid, Spain, 26 September 2025 -- Laboratorios Salvat, S.A. ("Salvat") announced today that the U.S. Food and Drug Administration (FDA) has approved Clotic (clotrimazole otic solution), the first and only treatment with clinical evidence specifically indicated for fungal otitis externa (otomycosis).

About Clotic

Clotic is a broad-spectrum otic antimycotic agent containing clotrimazole, an azole antifungal that inhibits fungal enzyme production essential for survival. The medication works by blocking cytochrome P450-dependent enzymes, damaging fungal cell walls and disrupting growth, ultimately causing cell death. This preservative-free formulation is administered as ear drops using innovative Blow-Fill-Seal technology in single-dose vials.

Clotic is indicated for the treatment of fungal otitis externa (otomycosis) in adults 18 years of age and older, specifically targeting infections caused by Aspergillus species and Candida species. The treatment is approved only for patients with intact tympanic membranes.

The FDA approval of Clotic was based on comprehensive clinical data demonstrating well-recognized safety and efficacy in treating pathogenic dermatophytes, yeasts, and several species of fungus affecting the outer ear canal. The approval package included analytical and clinical evidence supporting Clotic's effectiveness as the first clinically proven treatment option for otomycosis.

Clotic is administered twice daily for 14 days, with each single-dose vial (1%/0.17mL) delivering the complete treatment dose. The innovative packaging protects the preservative-free formulation from humidity and contamination while ensuring precise dosing.

The approval of Clotic marks an important milestone in addressing an underserved therapeutic area, offering the first FDA-approved treatment specifically designed and clinically validated for fungal otitis externa in adult patients.

Source: Clotic Prescribing Information, Laboratorios Salvat, S.A.

Manufactured by: PHARMALOOP, S.L., Madrid

For more information: www.svt.com | 1-954-218-1570