United States

FDA Expands The Use Of CERENIA® To Include Cats And Younger Puppies

Broadened label can ease suffering in even more patients

MADISON, NJ—May 31, 2012—Pfizer Animal Health announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for CERENIA® (maropitant citrate), the only FDA approved veterinary antiemetic medication. First approved for use in dogs, CERENIA Injectable Solution is now approved for treatment of vomiting in cats 16 weeks and older. The update also lowers the recommended age of use in dogs from 16 weeks to eight weeks, for the prevention and treatment of acute vomiting (for both injectable solution and tablets).

“CERENIA is the veterinarian-trusted solution for the treatment and prevention of acute vomiting in dogs,” said J. Michael McFarland, DVM, DABVP, group director of veterinary operations for the
Companion Animal Division of Pfizer Animal Health. “Because of the positive results of CERENIA and its importance among veterinary professionals and pet owners, Pfizer Animal Health was committed to providing the science to support this label update—so that cats and younger puppies may also be effectively treated for vomiting.”

Approved in the U.S. in 2007, CERENIA quickly became the veterinarians’ choice for vomiting relief. CERENIA has convenient once-daily dosing for ease of use. The injectable solution allows veterinarians to treat vomiting in the clinic, while the tablet formulation—for dogs eight weeks and older—allows patients to continue therapy at home, so that further vomiting is controlled and pet owners have peace of mind.

CERENIA is a NK-1 receptor antagonist. It works in the chemoreceptor trigger zone (CRTZ) and the emetic center, where all vomiting signals converge, to block stimuli from both central and peripheral pathways. This unique mode of action (MOA) provides broader efficacy than other commonly used antiemetics.

Some studies suggest that the activity of certain antiemetics with demonstrated efficacy in dogs may be less effective in cats.1,2 Dopamine is one neurotransmitter responsible for vomiting. In the dog, dopamine acts on the dopaminergic receptors. In the cat however, dopamine can also act on alpha adrenergic receptors. Therefore, antiemetics that primarily block dopaminergic receptors are not expected to work the same in cats as they do in dogs. In a field study, CERENIA stopped numerous causes of vomiting in cats via multiple pathways, thereby confirming the importance of NK-1 receptor antagonism in the physiology of vomiting.

Veterinarians who have questions about the label update should contact Pfizer Animal Health Customer Service at 1-855-424-7349.

IMPORTANT SAFETY INFORMATION

Important Safety Information: The safe use of CERENIA® has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens. The safe use of CERENIA has not been evaluated in patients with gastrointestinal obstruction, or patients that have ingested toxins. Use with caution in patients with hepatic dysfunction. CERENIA Injectable is recommended for dogs 8 weeks and older for prevention and treatment of acute vomiting and for cats 16 weeks and older for the treatment of vomiting. CERENIA Tablets are recommended for dogs 8 weeks and older for prevention of acute vomiting and for dogs 16 weeks and older for prevention of vomiting due to motion sickness. The most common side effects seen in dogs and cats administered CERENIA are pain/vocalization (injectable), depression/lethargy, anorexia, anaphylaxis, ataxia, convulsions, hypersalivation, and vomiting.

Prescribing Information

About Pfizer Animal Health

Pfizer Animal Health, a business unit of Pfizer Inc, is a world leader in the discovery, development and manufacture of innovative animal health vaccines, medicines, diagnostic products and genetic tests. Pfizer Animal Health invests more in research and development than any other animal health company. We work to assure a safe, sustainable global food supply from healthy beef and dairy cattle, swine, poultry, sheep and fish while helping dogs, cats and horses live healthier, longer lives. We strive to be the animal health company that provides full healthcare solutions to veterinarians, livestock producers, and pet owners. To learn more, visit www.pfizerah.com.

For further information, Contact:

Deron Johnson
Pfizer Animal Health
973-660-5567
Deron.Johnson@pfizer.com

Hannah Gardner
archer>malmo
901-523-2000
hgardner@archermalmo.com

1. Lucot JB and Crampton GH. Xylazine emesis, yohimbine and motion sickness susceptibility in the cat. J Pharmacol Exp Therap 1986;237:450-455
2. Jovanovic-Micic D, Samardzic R, and Beleslin DB. The role of alpha-adrenergic mechanisms within the area postrema in dopamine-induced emesis. European J Pharmacol 1995;272:21-30