SALVAT receives FDA approval for Clotic^®, an innovative treatment for otomycosis with Orphan Drug Designation

• This new drug, formulated with clotrimazole as its active pharmaceutical ingredient, addresses a significant unmet clinical need in the management of otomycosis. It offers a highly effective therapeutic option for alleviating the hallmark symptoms of fungal infections affecting the external auditory canal

• Following its commercial rollout in Spain in September 2025, it is scheduled for launch in the U.S. market in early 2026

Salvat Pharmaceutical Group has announced that the U.S. Food and Drug Administration (FDA) has approved 1% otic clotrimazole, the first targeted treatment for otomycosis, for commercialization in the United States.

Developed entirely by Salvat, the product will be manufactured at the company’s Pharmaloop facility in Alcalá de Henares (Madrid), which recently received FDA approval. This new approval marks a major scientific and industrial milestone for both Salvat and the broader Spanish pharmaceutical industry. It follows two prior FDA approvals for Salvat products and reinforces Pharmaloop’s international standing as a leading site for the production of sterile single-dose medicines using Blow-Fill-Seal (BFS) technology.

This new pharmaceutical product is presented as a sterile, single-dose otic solution designed to ensure optimal safety and dosing precision at the time of administration. Its innovative anhydrous formulation, containing 1% clotrimazole, enhances antifungal efficacy while maintaining an excellent safety and tolerability profile. Developed to address an unmet clinical need, it represents a significant therapeutic advancement in the management of otomycosis.  The product’s clinical performance was validated through Phase III clinical trials conducted across Europe, the United States, and Mexico.

“Otomycosis continues to pose a clinical challenge due to the lack of specific therapies and its high recurrence rate. In this context, 1% otic clotrimazole stands out as the treatment of choice, combining robust antifungal efficacy with an excellent safety profile” said Dr. Serafín Sánchez, President of the Spanish Society of Otolaryngology and Head and Neck Surgery (SEORL-CCC).

“This FDA approval underscores our commitment to scientific innovation and consolidates Salvat’s leadership in otology, while supporting our ongoing international expansion,” added Jordi Muntañola, CEO of Salvat Pharmaceutical Group.

The product is scheduled to be launched in the U.S. market in early 2026, following its commercial introduction in Spain and other European countries on September 1, 2025. The company will officially present the medicine in the Spanish market at the end of October during the 76th Congress of the Spanish Society of Otolaryngology and Head and Neck Surgery (SEORL-CCC), reaffirming its close relationship with the scientific community and its dedication to advancing clinical practice in ENT disorders.