FDA approves Mometamax Single

MSD Animal Health, a division of Merck & Co, Inc, announced that it has received FDA approval for its gentamicin, posaconazole, and mometasone furoate otic suspension (Mometamax Single; Merck). This latest addition to Merck’s portfolio is a new, convenient single-dose product for canine patients with otitis externa and will be available in veterinary clinics across the United States in summer 2025.

Jesse/stock.adobe.com

“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, MSD Animal Health.

“Therefore, Mometamax Single as a new option also alleviates stress for pet owners because veterinarians can administer a single dose in [the] clinic and ensure a safe, effective, and complete treatment regimen,” she continued.

Canine patients with otitis externa suffer from redness, swelling, and pain, with symptoms also including odor, constant head shaking, and discharge. It is currently one of the most commonly treated conditions within veterinary medicine, and, if left untreated, patients can develop chronic pain, hearing loss, and recurrent infections.

According to this release, this new product is indicated to treat otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in canine patients. It has 3 active ingredients—gentamicin, posaconazole, and mometasone furoate—and is the only FDA-approved, 1-dose, in-clinic product that is 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, MSD 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 1-time in-clinic approach,” she concluded.

This product is to be used in only canine patients and should be administered by a veterinary professional. Mometamax Single is also not to be used in dogs with known tympanic membrane perforation or with known or suspected hypersensitivity to gentamicin, posaconazole, or mometasone furoate. MSD Animal Health is instructing professionals to refer to the product label for full safety.

Reference

1. Epidemiological study of dogs with otitis externa in Cape Breton, Nova Scotia. News release. MSD Animal Health. May 2, 2025. Accessed May 8, 2025. https://www.msd-animal-health.com/2025/05/02/fda-approves-mometamax-single-to-treat-otitis-externa-in-dogs/