Tag: FDA approval

Summary:The FDA has approved Salvat Pharmaceutical Group’s 1% otic clotrimazole, Clotic, the first targeted treatment for otomycosis, marking a significant milestone in antifungal ear therapy. Key Takeaways: The product is reportedly the first specifically targeted treatment for otomycosis and demonstrated strong efficacy and safety in Phase III trials across multiple countries. Manufactured at Salvat’s FDA-approved Pharmaloop facility, it highlights Spain’s growing role in producing sterile, single-dose BFS medications. U.S. commercialization is planned for early 2026 following its European launch in September 2025. Salvat Pharmaceutical Group has announced that the U.S. Food and Drug Administration (FDA) has approved 1% otic clotrimazole, reportedly the first targeted treatment for otomycosis, for commercialization in the United States. Developed entirely by Salvat, the product, marketed as Clotic, 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, according to the company. It follows two prior FDA approvals for Salvat products and stands to reinforce Pharmaloop’s international reputation as a 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. According to the company, Clotic's 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,” says 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,” adds Jordi Muntañola, CEO of Salvat Pharmaceutical Group. The product, Clotic, 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.

Tag: FDA approval

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