Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the U.S. Food and Drug Administration (FDA) approval of MOMETAMAX SINGLE™ (gentamicin, posaconazole, and mometasone furoate otic suspension) – a new, convenient single-dose product for dogs to treat otitis externa. The product is expected to be available at veterinary clinics nationwide in summer 2025.
Canine otitis externa – inflammation of the external ear – is characterized by redness, swelling, and pain and is one of the most common conditions treated in veterinary practice. If left untreated, it can lead to chronic pain, hearing loss and recurrent infections. Otitis externa most commonly manifests as an acute condition or as an acute flare-up of a recurrent condition, and symptoms to be aware of include odor, discharge and constant head shaking. In fact, 1 in 7 dogs seen in general practice are affected by otitis externa.*
“Every case of otitis externa is unique and having a range of treatment options allows veterinarians to tailor care to each individual dog. MOMETAMAX SINGLE offers a convenient, in-clinic solution that expands our otic portfolio and supports our commitment to delivering flexible, effective treatment options,” said Christine McKinney, DVM, DACVD, small animal dermatology specialist, veterinary insights and medical affairs, Merck Animal Health. “Therefore, MOMETAMAX SINGLE as a new option also alleviates stress for pet owners because veterinarians can adminster a single dose in-clinic and ensure a safe, effective and complete treatment regimen.”
MOMETAMAX SINGLE is indicated for the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs. Formulated with a unique combination of three active ingredients (gentamicin, posaconazole, and mometasone furoate), MOMETAMAX SINGLE is the only one dose in-clinic product labeled to treat Pseudomonas aeruginosa.
“MOMETAMAX SINGLE represents our newest innovation in the otitis space, and we are proud to deliver this differentiated product that provides an effective treatment for dogs and peace of mind to pet owners,” said Alison De Leon, VMD, director, global pharmaceutical development, Merck Animal Health. “Daily treatment can be a challenge for busy pet parents, especially when their dog is suffering from a painful condition like otitis. In such cases, MOMETAMAX SINGLE offers an effective, convenient alternative. By expanding our otic portfolio, we’re giving veterinarians greater flexibility to choose the right treatment path for each individual case, whether that’s daily at-home care or a one-time in-clinic approach.”
As a first line treatment, MOMETAMAX SINGLE (gentamicin, posaconazole, and mometasone furoate otic suspension) builds on the proven efficacy of MOMETAMAX® with the convenience of a single-dose treatment. In the U.S. field study, 80.5% of treated dogs showed complete resolution of clinical signs versus 19.6% of dogs receiving placebo.**
Important Safety Information
MOMETAMAX SINGLE™ is for otic use in dogs only. Do not use in cats. MOMETAMAX SINGLE should be administered by veterinary personnel. Do not use in dogs with known tympanic membrane perforation. The integrity of the tympanic membrane should be confirmed before administering the product. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. Do not use in dogs with known or suspected hypersensitivity to gentamicin, posaconazole, or mometasone furoate. Avoid contact with eyes. For complete instructions and safety information, refer to the product label. For additional product information, please visit www.mometamax-single.com.
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Posted by Lizon May 6 2025. Filed under Current Articles, Featured.
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