15 drugs received approval in 2007, FDA reports

Slentrol, Vetmedin, Cerenia rank among what agency officials characterize as "new therapeutic advances"

Published: July 23, 2008
By Jennifer Fiala

Rockville, Md. — The Food and Drug Administration (FDA) characterizes fiscal year 2007 as "the year of the companion animal."

In a report issued today, the agency reveals that the Center for Veterinary Medicine (CVM) approved 15 original or supplemental New Animal Drug Applications (NADAs) intended to improve pet health. Of last year's approvals, 12 were for dogs, two were for cats and one was for horses. 

Among the new chemical entities are Pfizer Animal Health's Slentrol (dirlotapide), the first drug approved to manage canine obesity in the United States and Vetmedin (pimobendan), a drug manufactured by MEDA Manufacturing GmbH for Boehringer Ingelheim Vetmedica, Inc. It's designed to manage congestive heart failure and dogs. Cerenia (maropitant citrate), another Pfizer product, is the first in a new class of drugs that's prescribed to prevent acute vomiting in dogs. 

Other newly approved chemical entities include: 
  • Dexmedetomidine hydrochloride, a sedative, analgesic and pre-anesthetic in dogs
  • Moxidectin/imidacloprid, a treatment for roundworms, hookworms, whipworms, and fleas, and prevention of heartworm disease in dogs; and treatment of roundworms, hookworms, ear mites, fleas and prevention of heartworm disease in cats
  • Fluoxetine hydrochloride, a treatment of separation anxiety in conjunction with behavior modification in dogs
  • Diclazuril, a treatment of equine protozoal myeloencephalitis
  • Paziquantel/emodepside, a for treatment of roundworms, hookworms, and tapeworms in cats
  • Spinosad, a treatment to kill fleas and prevent and treat fleas on dogs for a month. 

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