FDA Approves MSD Animal Health’s MOMETAMAX SINGLE™ to Treat Otitis Externa in Dogs
The leading manufacturer of otic treatments expands portfolio with the only FDA-approved, one dose, in-clinic treatment for Pseudomonas aeruginosa and other pathogens
RAHWAY, N.J., May 02, 2025 – MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced 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, one in seven 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, MSD 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, 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 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.
About MSD Animal Health
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of MSD. Through its commitment to The Science of Healthier Animals®, MSD Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com and connect with us on LinkedIn and X (formerly Twitter).
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
References:
*Perry, Laura R et al. “Epidemiological study of dogs with otitis externa in Cape Breton, Nova Scotia.” The Canadian veterinary journal = La revue veterinaire canadienne vol. 58,2 (2017): 168-174.
**Freedom of Information Summary, NADA 141-600.