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FDA Approves Trio Of New Canine Drugs



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The U.S. Food and Drug Administration approved three new animal drugs for dogs, including a formulation of Novartis Animal Health’s Interceptor heartworm preventive, a transdermal fentanyl solution for control of postoperative pain and an antibiotic for treatment of secondary superficial bacterial pyoderma, the agency reported today.

Novartis received FDA approval for Interceptor Spectrum Chewable Tablets, which adds praziquantel to the milbemycin oxime found in original Interceptor Flavor Tabs. Praziquantel is an anthelmintic and is found in Virbac Animal Health’s Iverhart Max Chewable Tablets.

Both Interceptor and Interceptor Spectrum are indicated for prevention of heartworm disease, but while original Interceptor is indicated for control of adult Ancylostoma caninum (hookworm) and removal and control of Toxocara canis and Toxascaris leonine (roundworms) and Trichuris vulpis (whipworm) infections, Interceptor Spectrum is indicated for treatment and control of adult A. caninum, T. canis, T. leonine, T. vuplpis, and Taenia pisiformis, Echinococcus multilocularis and E. granulosus (tapeworm).

Also, while original Interceptor is indicated for dogs and puppies at least 4 weeks old and 2 pounds, Interceptor Spectrum is indicated for dogs and puppies at least 6 weeks old and 2 pounds.

The FDA also approved Nexcyon Pharmaceuticals Inc.’s Recuvyra (fentanyl) Transdermal Solution for control of postoperative pain associated with surgical procedures in dogs. Fentanyl is a powerful synthetic opiate similar but more potent than morphine, according to the U.S. National Institutes of Health.

Finally, the FDA approved Virbac Animal Health Inc.’s Rilexine (cephalexin) Chewable Tablets for Dogs for the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius. Cephalexin is a cephalosporin antibiotic used in human medicine to treat certain infections caused by bacteria such as pneumonia and bone, ear, skin and urinary tract infections, according to the NIH.

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