Claro Approval

SHAWNEE, Kan., Bayer HealthCare LLC Animal Health announces the approval of Claro™ (15.0 mg/mL florfenicol, 13.3 mg/mL terbinafine, 2.0 mg/mL mometasone furoate) Otic Solution, the first single-dose therapy proven to effectively treat susceptible strains of common pathogens found in canine otitis externa.1 The product is expected to be available for sale exclusively to veterinarians in November.

Otitis externa is the second most common reason dog owners take their pet to a veterinarian2 and can be a frustrating disease for canine patients and their owners.  The condition is an inflammation of the ear canal that is often accompanied by secondary infections.  It frequently causes pain, itching, a strong odor and/or muffled hearing in affected dogs and typically requires client administration of ear medications at home.

Claro™ is intended to be a first-line otitis externa therapy that addresses the needs of veterinarians and dog owners.  It is a clear liquid solution featuring a fixed combination of antibacterial, antifungal, and anti-inflammatory ingredients that requires only one, veterinarian-administered treatment.  The unique single-dose treatment regimen eliminates veterinarian uncertainty about pet owner compliance and spares pet owners the frustrations of in-home application and multiple treatment visits.

Claro™ was developed by Piedmont Animal Health, Greensboro, NC, as part of a development partnership with Bayer.

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.  CLARO™ is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.

About Claro™
Claro™ is indicated for the treatment of canine otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).  One dose is administered to each affected ear in dogs of all sizes. Do not use Claro™ on dogs with known tympanic membrane perforation. Claro™ is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride or mometasone furoate.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available

About Piedmont Animal Health
Piedmont Animal Health (part of Piedmont Pharmaceuticals) is led by a team of seasoned veterinary pharmaceutical innovators that has developed, launched, or marketed more than 20 companion animal health products. Today, these products represent approximately 25 percent of the total revenue in the U.S. small animal veterinary segment. A leader in innovation, Piedmont is dedicated to developing products that improve compliance and ease of use. For more information, visit