FDA approves Bayer's ProstaMate and OvaCyst

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Bayer HealthCare LLC Animal Health Division received approval from the Food and Drug Administration (FDA) to market ProstaMate™ (dinoprost tromethamine) and OvaCyst™ (gonadorelin diacetate tetrahydrate) for indications in support of reproduction management as prescribed by veterinarians. ProstaMate is indicated for use in cattle, swine and mares; OvaCyst for use in dairy cattle.

“Efficient reproduction is the cornerstone of successful dairy production and cattle herd management,” says Dr. Milo Wiltbank, Professor of Reproductive Physiology, Department of Dairy Science, University of Wisconsin. “The proper use of reproductive hormones provides veterinarians and producers effective options that will help reduce labor costs, increase the productivity of their cows and improve the efficiency of their operations.”

Two of Bayer’s newest products, acquired through the Teva acquisition, ProstaMate, and OvaCyst, have been among the leading reproduction management product choices for veterinarians and producers for years.

“We are proud to bring these useful products back to the veterinarians and producers who need them,” said Cary Christensen, DVM, Director, Food Animal & Equine

Business Unit, Bayer HealthCare Animal Health. “We are committed to these important brands and will leverage Bayer’s 150 years of science for a better life experience and ongoing dedication to quality to supporting the market and our customers.”

About Bayer HealthCare Animal Health’s Reproduction Management Products
ProstaMate sterile solution is indicated for intramuscular use for estrus synchronization, treatment of unobserved estrus and chronic endometritis in cattle; for parturition induction in swine; and for controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.

OvaCyst sterile solution is indicated for the treatment of cystic ovaries in dairy cattle. OvaCyst initiates the release of normal physiological levels of endogenous LH (luteinizing hormone) to cause ovulation and luteinization.

ProstaMate and OvaCyst are both currently available through Bayer-approved distributors. ProstaMate is approved for intramuscular (IM) administration only, in 30 mL and 90 mL vials, with recommended dosages for cattle at 25 mg (5 mL)/cow; for swine at 10 mg (2 mL)/pig; and for horses at 1 mg/100 lb of body weight (usually 1-2 mL)/mare. OvaCyst, available in 12 mL and 36 mL vials, is approved for intravenous (IV) or IM injection in dairy cattle with a recommended dosage of 100 mcg
(2 mL)/cow.

For more information about ProstaMate and OvaCyst, or to obtain a product label, call Bayer Veterinary Services at +1 (800) 422-9874 or visit www.bayerlivestock.com.

Federal law restricts these drugs to use by or on the order of a licensed veterinarian. Not for use in humans. Non-steroidal anti-inflammatory drugs may inhibit prostaglandin synthesis; therefore this class of drugs should not be administered concurrently. Non-steroidal anti-inflammatory drugs may inhibit prostaglandin synthesis; therefore this class of drugs should not be administered concurrently.



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