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US FDA approves Simplicef to treat skin infections in dogs

MarylandTuesday, August 31, 2004, 08:00 Hrs  [IST]

The Food and Drug Administration has approved a new antibiotic drug for dogs, giving veterinarians a new once-daily treatment option to treat skin infections (wounds and abscesses) which are common problems among dogs. According to an FDA release, the product -Simplicef (cefpodoxime proxetil)- was developed by Pharmacia & Upjohn Co of Kalamazoo, Michigan, a division of Pfizer Inc. The drug is an extended spectrum cephalosporin that is effective in the treatment of skin infections in dogs caused by susceptible strains of Staphylococcusintermedius, Staphylococcusaureus, Streptococcuscanis, Escherichiacoli, Pasteurellamultocida, and Proteusmirabilis. "This approval should provide significant help to veterinarians and dog owners," Dr. Lester M. Crawford, acting FDA commissioner said adding, "It represents the progress that FDA and the animal medical community has made in helping to provide better medical treatment to our pets." The drug was originally approved for human use, but the company decided to develop the product for dogs by fulfilling FDA's requirements for an original New Animal Drug Application. Veterinarians are permitted under law to use certain drugs approved for human use to treat dogs and other pets, a procedure known as prescribing drugs in an "extra label" manner. While veterinarians have often used a human-use antimicrobial in these cases, having a product that is thoroughly evaluated and approved specifically to treat skin infections in dogs provides veterinarians with exact information on how to administer the treatment and assess its results, the release added. The drug is a film-coated tablet given to the dog orally once a day. It will be available by veterinarian prescription starting this fall.

 
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