Highly Effective Deworming Treatment for New Species
SUMMIT, N.J., February 12, 2014 – Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorization for the veterinary medicinal product PANACUR® AquaSol (fenbendazole 200 mg/mL) for use in chickens.
PANACUR® AquaSol is a water-administered dewormer that has been shown to have a highly stable suspension in water. It is currently available in Europe for use in swine.
If adopted, approved indication:
PANACUR® AquaSol will be indicated for the treatment of gastro-intestinal nematodes in chickens infected with:
- Ascaridia galli (L5 and adult stages)
- Heterakis gallinarum (L5 and adult stages)
Detailed conditions of the product, including the zero day withdrawal period for eggs, six day withdrawal period for meat and offal, will be described in the summary of product characteristics (SPC) which will be published on the European Medicines Agency’s website in and will be available after the marketing authorization has been granted by the European Commission.
About Merck Animal Health
Today’s Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).