OVERLAND PARK, Kan. (January 31, 2005) ” Fort Dodge Animal Health, a division of Wyeth (NYSE: WYE), announced today that the Veterinary Medicine Advisory Committee (VMAC) did not reach a consensus regarding its review of safety data for ProHeart 6. The committee commented on the breadth and complexity of the data presented today and difficulty in drawing firm conclusions. The VMAC is the advisory committee to the Food and Drug Administration’s Center for Veterinary Medicine (CVM).
“”Fort Dodge Animal Health will continue to work closely with the CVM to resolve any remaining concerns with the product,”” said Rami Cobb, Vice President of Pharmaceutical Research and Development for Fort Dodge Animal Health. “”We feel strongly the thorough testing, comprehensive analysis of the related data and findings of independent scientific experts have demonstrated ProHeart 6 is safe and effective.””
During today’s advisory committee meeting, the panel heard and deliberated on product data presented by Fort Dodge Animal Health, an expert veterinary epidemiologist and representatives from the CVM. Fort Dodge’s presentation focused on the results of an extensive and rigorous review of ProHeart 6, and included the evaluations and conclusions of independent scientific experts.
Lawrence Glickman, VMD, DrPh, FACE, Professor of Epidemiology and Public Health, and Head of the Clinical Epidemiology Section, School of Veterinary Medicine, Purdue University, analyzed data from nearly seven million canine visits at more than 400 hospitals in the Banfield, The Pet HospitalTM practice. Dr. Glickman’s presentation to VMAC, which was based on thorough evaluation of these data, concluded the safety profile of ProHeart 6 appeared similar to two commonly used monthly oral heartworm preventatives, and the results of this study provided no support for the recall of ProHeart 6 from the veterinary market.
“”Based on thorough testing of the product and comprehensive analysis of the related data, we are confident in the safety and efficacy of ProHeart 6 and believe it has proven to be of significant benefit to both veterinarians and pet owners in the prevention of potentially deadly heartworm disease,”” said Cobb.
Fort Dodge Animal Health, a division of Wyeth (NYSE: WYE), is a leading manufacturer and distributor of prescription and over-the-counter animal health care products for the livestock, companion animal, equine, swine and poultry industries in North America and international markets. Key products include West Nile-InnovatorTM, CYDECTIN® Pour-On, Duramune® Adult, QUEST® Gel and EtoGesic® Tablets. The company is headquartered in Overland Park, Kan.