- Cronus Pharma has launched Florfinasone Otic for the treatment of otitis externa in dogs.
- The product is FDA approved under ANADA #200-848.
- Florfinasone Otic combines florfenicol, terbinafine and mometasone furoate to provide antibacterial, antifungal and anti-inflammatory activity.
- The product is indicated for canine otitis externa associated with susceptible strains of Malassezia pachydermatis and Staphylococcus pseudintermedius.
- Florfinasone Otic is supplied as a single-use formulation in cartons containing 10 dropperettes, each with a 1 mL dose.
- The product is not for use in cats.
Cronus Pharma has launched Florfinasone Otic, an FDA-approved fixed-combination therapy for treating otitis externa in dogs associated with susceptible strains of yeast and bacteria.
The product is indicated for canine otitis externa associated with susceptible strains of Malassezia pachydermatis and Staphylococcus pseudintermedius.
Florfinasone Otic combines three active ingredients to provide antibacterial, antifungal and anti-inflammatory activity in a single-use formulation.
Three active ingredients target components of otitis externa
Florfinasone Otic contains 16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine, equivalent to 16.6 mg/mL terbinafine hydrochloride, and 2.2 mg/mL mometasone furoate.
Florfenicol is a bacteriostatic antibiotic that acts by inhibiting protein synthesis.
Terbinafine is an antifungal agent that selectively inhibits the early synthesis of ergosterol, while mometasone furoate is a glucocorticosteroid with anti-inflammatory activity.
Janel Fisher, vice president of sales at Cronus Pharma, said the launch expands the company’s portfolio with a treatment option addressing susceptible bacterial, fungal and inflammatory components associated with canine otitis externa.
FDA approval and administration
Florfinasone Otic is approved by the U.S. Food and Drug Administration under ANADA #200-848.
The product is available in cartons containing 10 single-use dropperettes, with each dropperette containing a 1 mL dose.
Proper patient selection is important when veterinarians consider the benefits and risks of using Florfinasone Otic. The integrity of the tympanic membrane should be confirmed before the product is administered.
Florfinasone Otic is not for use in cats.
Product available through veterinary distributors
Cronus Pharma said Florfinasone Otic is available to veterinarians through national and regional distributors.
Based in East Brunswick, New Jersey, Cronus Pharma is a privately held veterinary generic pharmaceutical company with research, development, manufacturing and marketing operations.
Information sourced from the company’s press release.
