Merck Animal Health receives FDA approval for AROVYN™

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Merck Animal Health introduces AROVYN, a broad-spectrum antibiotic that treats key organisms associated with bovine respiratory disease, foot rot and conjunctivitis.

Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, New Jersey, USA (NYSE: MRK), today announced today received US FDA approval for AROVYN™ (tulathromycin injection) – a broad-spectrum prescription antibiotic that treats key organisms associated with bovine respiratory disease (BRD), foot rot and conjunctivitis.

“Merck Animal Health is delighted to add AROVYN to its comprehensive and reliable portfolio of cattle antimicrobials. AROVYN offers veterinarians a new option when prescribing tulathromycin – which has been proven to help treat some of the most common and costly bovine disease problems,” said David Sjeklocha, DVM, Director of Technical Services, Merck Animal Health. “While following vaccination protocols can certainly help keep animals healthy, some animals will still get sick. The new AROVYN is intended for situations requiring early diagnosis and an effective treatment program, so animals can recover quickly.

In beef cattle and non-lactating dairy cattle, AROVYN is indicated for the treatment of BRD and the control of respiratory diseases in animals at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis . It is also approved for the treatment of pink eye or infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis, as well as for the treatment of footrot associated with Fusobacterium necrophorum and Porphyromonas levii. In lactating calves, dairy calves and veal calves, AROVYN is indicated for the treatment of BRDs associated with M. haemolytica, P. multocida, H. somni and M. bovis.

“Our commitment to continuously improving the health and welfare of cattle drives our work to bring new vaccines, diagnostic technologies and antimicrobials to market,” said Dr. Sjeklocha. “Over the past 18 months, to help our customers better manage BRD, Merck Animal Health has introduced two innovative diagnostic technologies WHISPER® ON ARRIVAL and SenseHub® Feedlot, a first-of-its-kind intranasal vaccine BOVILIS® NASALGEN® 3- PMH and now AROVYN, an important antimicrobial in many livestock treatment protocols.

AROVYN – a prescription antibiotic for cattle and pigs – will be available from or by order of a licensed veterinarian from May 2022. It will be available in 100, 250 and 500ml bottles. It is manufactured in the same facility as other Merck Animal Health antimicrobials, such as ZUPREVO® (tildipirosin), with the same high quality assurance guidelines.

To learn more about AROVYN, visit www.merck-animal-health-usa.com.

IMPORTANT SAFETY INFORMATION

CATTLE: AROVYN has a pre-slaughter withdrawal period of 18 days in cattle. Do not use in female dairy cows 20 months or older. Do not use in animals known to be hypersensitive to the product. See complete prescribing information.

PIGS: The withdrawal period for AROVYN in pigs is five days. AROVYN should not be used in animals known to be hypersensitive to the product.

For more than 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, delivering medicines and vaccines for many of the world’s toughest diseases. Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, NJ, USA, is the global animal health business unit of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, breeders, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and veterinary solutions and services. health management, as well as a full suite of connected technologies that includes identification, traceability and control products. Merck Animal Health is dedicated to preserving and improving the health, welfare and performance of animals and the people who care for them. It invests heavily in dynamic and comprehensive R&D resources and a modern global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.comand join us onLinkedIn, Facebook ,Twitter, instagram.

Boyd S. Abbott