• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

GONAbreed - Veterinarians

May 22, 2013


Dear Bovine Veterinarian:

The U.S. Food and Drug Administration (FDA) would like to announce there is now an approved product, GONAbreed, a sterile injectable solution of gonadorelin acetate. When used in combination with cloprostenol, the product is approved for synchronizing estrous cycles to allow for fixed time artificial insemination in lactating dairy and beef cows. FDA also wants to remind you of the benefits of using FDA-approved drugs.

Drug Information
 

  GONAbreed Injectable Solution
ManufacturerParnell Technologies Pty Ltd
Application TypeAbbreviated New Animal Drug Application (ANADA)
Application Number200-541
Indications
  1. For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination in lactating dairy and beef cows.
  2. For treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus. GONAbreed initiates release of endogenous luteinizing hormone to cause ovulation and luteinization.
     
Active IngredientGonadorelin acetate
Concentration100 mcg gonadorelin (as gonadorelin acetate)/mL
How Supplied20 mL and 100 mL multidose vials
Dispensing StatusPrescription
Clinical Pharmacology

Endogenous gonadorelin is the hypothalamic releasing factor that causes the anterior pituitary gland to release gonadotropins, such as luteinizing hormone (LH) and follicle stimulating hormone (FSH). Endogenous gonadorelin is synthesized and/or released from the hypothalamus during various stages of the bovine estrous cycle following appropriate neurogenic stimuli.

Synthetic gonadorelin is physiologically and chemically identical to endogenous hypothalamic releasing factor. When administered intravenously or intramuscularly, synthetic gonadorelin also causes the release of LH or FSH from the anterior pituitary gland.
 

 Please see the approval notice and Freedom of Information Summary for GONAbreed.

Benefits of FDA Approval

FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug company must prove to FDA that:

  • The drug is safe and effective for a specific use in a specific animal species;
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity; and
  • The drug’s labeling is truthful and non-misleading.

For a drug to be used in food-producing animals, FDA’s approval process also ensures that food products, such as milk and beef, from treated animals are safe for people to eat.

FDA’s role does not stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor:

  • The drug’s safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
  • The manufacturing process to ensure quality and consistency are maintained; and
  • The drug’s labeling to make sure the information remains truthful and non-misleading.

Other Gonadorelin Products

Five other gonadorelin (GnRH) products are FDA-approved to treat cystic ovaries in dairy cows; none of which are FDA-approved for use in combination with another drug for synchronizing estrous cycles in lactating dairy and beef cattle. Using one of these GnRH products for estrous synchrony in combination with another drug is considered an illegal extra-label use.

By prescribing FDA-approved GONAbreed, you’re choosing the only marketed GnRH product shown to be safe and effective for use in combination with cloprostenol for synchronizing estrous cycles. Used together in a cattle breeding program, GONAbreed and cloprostenol synchronize estrous cycles to allow for fixed time artificial insemination in lactating dairy and beef cows.

FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals. For more information, please contact the CVM Communications Staff at 240-276-9300 or AskCVM@fda.hhs.gov.

Sincerely,
 

Daniel G. McChesney, Ph.D.
Director, Office of Surveillance and Compliance
Center for Veterinary Medicine