🏅 FDA Orphan Designation

Clotic

clotrimazole

Manufacturer: Laboratorios Salvat, S.A.

Indicated for:

Transient congenital hypothyroidism due to maternal factorOrphanCHIME syndromeCongenital enteropathy due to enteropeptidase deficiency

FDA-Approved Indications (3)

Transient congenital hypothyroidism due to maternal factorOrphan Designation

treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older

CHIME syndrome

indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older

Population: adults ≥18 years

Congenital enteropathy due to enteropeptidase deficiency

indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older

Population: adults ≥18 years

Indications & Usage

1 INDICATIONS AND USAGE CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes. CLOTIC is an azole antifungal indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. ( 1 ) Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes

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Clotic

Laboratorios Salvat, S.A.

Clotic

Laboratorios Salvat, S.A.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.