Merck Animal Health Receives Positive CVMP Opinion for Formulation of BRAVECTO
Merck Animal Health Receives U.S. FDA Approval of Expanded Indication for BRAVECTO (fluralaner) Chews for Dogs
MADISON, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE:MRK), and Virbac (NYSE Euronext:VIRP) today announced that the companies have signed a definitive agreement under which Merck Animal Health would acquire the U.S. rights to SENTINEL® FLAVOR TABS® and SENTINEL® SPECTRUM® Chews in the Companion Animal category. Merck Animal Health will make a cash payment of approximately $400 million to acquire the SENTINEL branded products in the United States at closing of the acquisition.
Merck Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), today announced the U.S. approval of BRAVECTO® PLUS topical solution for cats by the U.S. Food and Drug Administration (FDA). BRAVECTO PLUS is an extended-duration, broad-spectrum combination (fluralaner and moxidectin) topical solution for cats, indicated for both external and internal parasite infestations: ticks and fleas, heartworm, intestinal roundworm and hookworm. This unique formula in BRAVECTO PLUS provides extended protection for up to two months with just one application, making it the only product on the market to protect against this combination of parasites at a longer duration. BRAVECTO PLUS is expected to be available in the coming months.
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 December 2018
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Bravecto Plus (fluralaner/moxidectin), from Intervet International B.V., a new combination product for the treatment of tick and flea infestations and nematodes in cats.
The European Medicines Agency (EMA) concluded in July 2017 that Bravecto, a medicine that treats tick and flea infestations in dogs and cats, continues to have an acceptable safety profile. However, the company that markets the product will have to update the package leaflet and include convulsions as a new side effect that is reported very rarely, i.e., less than one animal out of 10,000 animals treated. Veterinarians and pet owners will also be advised to use Bravecto with caution in dogs with epilepsy.