CERENIA® (maropitant citrate) Injectable Solution Label Approved for Intravenous Administration
FLORHAM PARK, N.J. – Jan. 14, 2016 – Zoetis Inc. today announced that the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) has approved an update to the labeling for CERENIA® (maropitant citrate) Injectable allowing for intravenous administration during surgical protocols using emetogenic medication, or medication that induces vomiting. Previously approved only for subcutaneous injection, this CERENIA label update gives veterinarians the flexibility of an additional delivery option to help prevent vomiting in canine and feline patients.
In two separate bioequivalence studies conducted in 2015 by Zoetis in dogs and cats1,2, when delivered intravenously, CERENIA reached concentration and absorption levels as quickly as with subcutaneous injection. Additionally, two separate safety studies in dogs and cats3,4 indicated no related effects on survival or clinical findings, and there were no reports of pain on intravenous injection.
“The label update for intravenous administration gives veterinarians more in-clinic flexibility for how and when we can treat patients with CERENIA, and this added flexibility is likely to improve canine surgical outcomes that ultimately benefit the animal by helping avoid complications such as aspiration pneumonia,” said Tamara Grubb, DVM, PhD, diplomate, American College of Veterinary Anesthesia & Analgesia and assistant professor of anesthesia & pain management, Washington State University. David Twedt, DVM, diplomate of the American College of Veterinary Internal Medicine and professor of medicine at Colorado State University added, “Our recent study5 and clinical experience have demonstrated that patients are more comfortable and return to feeding more quickly when CERENIA is prescribed preoperatively prior to anesthesia for surgical and medical procedures.”
CERENIA Injectable is indicated for the prevention and treatment of acute vomiting in dogs two months of age and older, the prevention of vomiting in dogs four months of age and older caused by emetogenic medication or chemotherapeutic agent and for the treatment of vomiting in cats four months of age and older. Please visit cereniadvm.com for more information.
IMPORTANT SAFETY INFORMATION:
Use CERENIA Injectable for vomiting in cats 4 months and older; use subcutaneously for acute vomiting in dogs 2 to 4 months of age or either subcutaneously or intravenously in dogs 4 months of age and older. Use CERENIA Tablets for acute vomiting in dogs 2 months and older, and for prevention of vomiting due to motion sickness in dogs 4 months and older. Safe use has not been evaluated in cats and dogs with gastrointestinal obstruction, or those that have ingested toxins. Use with caution in cats and dogs with hepatic dysfunction. Pain/vocalization upon injection is a common side effect. In people, topical exposure may elicit localized allergic skin reactions, and repeated or prolonged exposure may lead to skin sensitization. See full Prescribing Information or call 1-888-ZOETIS1 (963-8471) for more information.
Zoetis (zô-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. In 2014, the company generated annual revenues of $4.8 billion. With approximately 10,000 employees worldwide at the beginning of 2015, Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in 120 countries. For more information, visit www.zoetisUS.com.
For Further Information,Contact:
1. Data on file, Study Report No. A461N-US-13-289, 2015 Zoetis Inc.
2. Data on file, Study Report No. A461N-US-13-080, 2015 Zoetis Inc.
3. Data on file, Study Report No. A366N-US-13-276, 2015 Zoetis Inc.
4. Data on file, Study Report No. A386N-US-13-077, 2015 Zoetis Inc.
5. Marquez M, Boscan P, Weir H, Vogel P, Twedt DC. Comparison of NK-1 receptor
antagonist (maropitant) to morphine as a pre-anaesthetic agent for canine
ovariohysterectomy. PLoS One. 2015;10(10):e0140734. doi:10.137/journal.pone.0140734.
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