FDA Approves New ULCERGARD® (omeprazole) Product Label
November 28, 2006
Duluth, Ga., — Merial today announced that the Food and Drug Administration (FDA) has approved a new product label for its equine stomach ulcer product - ULCERGARD, the only FDA-approved product proven to prevent stomach ulcers in horses. The revised label provides the central claim that, when given once daily, ULCERGARD is effective in preventing stomach ulcers in horses exposed to stressful periods. The new label further expands those situations in which ULCERGARD can be used and highlights the product's effectiveness in preventing stomach ulcers over both short and long periods of time.
"We are pleased to have received FDA approval on the new ULCERGARD product label," said Jeannine Courser, Product Manager, Merial Equine Pharmaceuticals. "All kinds of stressful periods in a horse's life can lead to stomach ulcers, but we know that ULCERGARD will prevent ulcers during these times. The new FDA approved label provides fewer restrictions for product use and will allow both veterinarians and horse owners to try ULCERGARD in situations that may not commonly be perceived as times when stomach ulcers can occur, but in fact are."
Many times situations, such as when a horse is confined, training, traveling, competing, are stressful and are commonly recognized as optimal times to prevent stomach ulcers with ULCERGARD. This is especially true because during these situations ulcers have been shown to occur in as little as five days1. There are, however, other stressful lifestyle situations where horses may benefit from proactive ulcer prevention. For example, horses may be given ULCERGARD when hospitalized or being laid-up, during the weaning process or when they are being fed low roughage and/or a high grain diet.
Available through veterinarians, ULCERGARD is a once-daily (four daily doses per tube), cinnamon flavored oral paste. It's active ingredient - omeprazole - suppresses acid production and prevents stomach ulcers. ULCERGARD is the only product that is FDA-approved for the prevention of equine stomach ulcers.
For more information on preventing stomach ulcers in horses, visit www.ULCERGARD.com.__________________
1McClure SR, Carithers DS, Gross, SJ, Murray MJ. Gastric ulcer development in horses in a simulated show or training environment. J Am Vet Med Assoc;2005;227:775-777.
®ULCERGARD is a registered trademark of the AstraZeneca Group of Companies. ©2006 Merial Limited, Duluth, GA.
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Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2005 sales were in excess of $1.9 billion. Merial Limited is a joint venture between Merck & Co. and sanofi-aventis. For more information, please see www.merial.com.