FDA clears reintroduction of ProHeart 6 to the veterinary channel

FDA clears reintroduction of ProHeart 6 to the veterinary channel

New rules call for client consent, veterinarian training program starting June 12.
Jun 06, 2008
By dvm360.com staff

Overland Park, Kan. - ProHeart 6 is back. In fact, the injectable heartworm preventive (moxidectin) from Fort Dodge Animal Health was reintroduced to the market today following approval from the Food and Drug Administration (FDA). The announcement follows an exhaustive review from FDA's Center for Veterinary Medicine (CVM) since its voluntary recall in 2004.

The review, according to Fort Dodge Animal Health, was based on an "extensive body of scientific data and international experience, which support the decision to return this life-saving product to the market."

Rami Cobb, BVSC (Hons), MACVSc, senior vice president of pharmaceutical research and development for Fort Dodge Animal Health, says in a prepared statement, "We are extremely pleased to bring ProHeart 6 back to veterinarians and pet owners throughout the United States, as it has safely and effectively protected millions of dogs around the world against potentially deadly heartworm disease." Our first and foremost priority continues to be providing products that help ensure the health and well being of all animals."

"At the time of the voluntary U.S. recall in 2004, we believed it was in the best interest of veterinarians and pet owners to thoroughly address the concerns of the CVM before continuing the marketing of this product in the United States. We have always maintained our confidence in ProHeart 6 and the unique medical benefits it brings to veterinary medicine. Fort Dodge has worked with the CVM to address its questions and feels the scientific data, as well as our vast experience with the product internationally, supports confidence in the product and its return to the U.S. market," Cobb explains.

The product is approved in Australia, Mediterranean regions of Europe and Japan. In the United States, the American Heartworm Society reports that 250,000 pets tested positive for heartworm infection in 2004.

As part of the product's return to the U.S. veterinary market, Fort Dodge has created a post-marketing surveillance initiative based on similar programs to monitor the safety of human drugs.

This program includes comprehensive veterinarian training, pet owner education, consent forms and specific requirements for the purchase of Proheart 6. Fort Dodge reports this post-marketing initiative allows the company to gather additional product data and maintain active communication with veterinarians and CVM.

Veterinarians who want to purchase ProHeart 6 will be required to register with Fort Dodge Animal Health and participate in a Web-based training program scheduled for Thursday, June 12 at 1 p.m. EST. To register, go to www.vetsymposium.com/proheart6. If you are unable to attend this session, veterinarians can log on any time beginning Friday, June 13. For more information call the company's Professional Services department at (800) 533-8536.