MSD Animal Health Receives Positive Final Opinion from European Medicines Agency for BRAVECTO™ (fluralaner) Spot-On for Cats and Dogs
22.3.2016 08:00 | Business Wire
MSD Animal Health (known as Merck Animal Health in 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 final opinion, recommending the granting of a marketing authorization for the veterinary medicinal product BRAVECTO™ (fluralaner) Spot-On for both cats and dogs.
In 2014, BRAVECTO was launched as a chew for dogs providing protection with its active ingredient, fluralaner, against fleas and ticks for up to 12 weeks with a single treatment. BRAVECTO Spot-On provides 12 weeks of flea and tick protection for both cats and dogs with the same active ingredient as BRAVECTO chew. More than 13 million doses of BRAVECTO have been dispensed in 60 countries since its introduction.
BRAVECTO Spot-On will be the first product to provide immediate and persistent systemic flea and tick protection for cats and gives veterinarians and dog owners a choice in how to administer flea and tick protection. BRAVECTO Spot-On can be used to treat Flea Allergy Dermatitis (FAD) in dogs and also cats.
If adopted, BRAVECTO Spot-On will be indicated for the treatment of tick and flea infestations on cats and dogs. It is a systemic insecticide and acaricide that provides immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks in cats and dogs.
Fleas and ticks must attach to the treated animal and commence feeding in order to be exposed to the active substance. The most common side effects in dogs are mild and transient skin reactions such as erythema or alopecia at the application site and, in cats, pruritus at the application site.
BRAVECTO Spot-On is applied using the company’s unique “Twist’n’Use”™ pipette design for ease of application. Detailed conditions of the product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available after the marketing authorization has been granted by the European Commission.
About MSD Animal Health
For 125 years, MSD has been a global health care leader working to help the world be well. MSD Animal Health, known as Merck Animal Health in the United States and Canada, is the global animal health business unit of MSD. Through its commitment to the Science of Healthier Animals™, MSD Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. MSD 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. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com or connect with us on LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. 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; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company 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 the company’s 2015 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).
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