Animal & Veterinary

GONABREED - Veterinarians

May 22, 2013
Revised April 24, 2015
 

Dear Bovine Veterinarian:

In January 2013, FDA approved the first gonadotropin releasing hormone (GnRH) product, GONABREED, for estrous synchrony in lactating dairy cows and beef cows. GONABREED is a sterile injectable solution of gonadorelin acetate, and when used with cloprostenol sodium as part of a synchronization regimen, the drug can be used to synchronize estrous cycles to allow for fixed time artificial insemination in lactating dairy cows 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 (FTAI) in lactating dairy and beef cows.
  2. For the treatment of cystic ovaries in dairy cattle.
Active IngredientGonadorelin acetate
Concentration100 mcg gonadorelin (as gonadorelin acetate)/mL
How Supplied20 mL and 100 mL multidose vials
Dispensing StatusPrescription
Route of Administration
  1. Estrous synchrony indication: Intramuscular injection
  2. Cystic ovary indication: Intravenous or intramuscular injection
     
Dosage Regimen
  1. Estrous synchrony indication: The recommended intramuscular dosage is 100 mcg of gonadorelin (1 mL) per cow, used in estrous synchrony regimens similar to the following:
  • Administer the first GONABREED injection (1 mL) at Time 0.
  • Administer 500 mcg cloprostenol (as cloprostenol sodium) by intramuscular injection 6 to 8 days after the first GONABREED injection.
  • Administer the second GONABREED injection (1 mL) 30 to 72 hours after the cloprostenol sodium injection.
  • Perform FTAI 0 to 24 hours after the second GONABREED injection, or inseminate cows on detected estrus using standard herd practices.
  1. Cystic ovary indication: 100 mcg of gonadorelin (1 mL) per cow.
Clinical Pharmacology

Endogenous gonadorelin is the gonadotropin releasing hormone (GnRH) 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.

GONABREED is a sterile solution of synthetic gonadorelin and is physiologically and chemically identical to endogenous gonadorelin.

Endogenous gonadorelin, through release of LH, induces ovulation of dominant ovarian follicles present on the bovine ovary during the estrous cycle. GONABREED has the same effect as endogenous gonadorelin to induce ovulation.

Please refer to the Freedom of Information Summary and package insert for GONABREED before using the drug.

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 intended to be used in food-producing animals, FDA’s approval process also ensures that food products, such as milk and meat, 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 gonadorelin (GnRH) products are FDA-approved to treat cystic ovaries in dairy cows, but only three are also FDA-approved for use with another drug for synchronizing estrous cycles in lactating dairy cows: GONABREED, FACTREL, and FERTAGYL. GONABREED is also the only GnRH product FDA-approved for use with another drug for synchronizing estrous cycles in beef cows.

FDA-approved GnRH Products for Use with Another Drug for Estrous Synchrony

 FACTREL InjectionGONABREED Injectable SolutionFERTAGYL
Solution 
ManufacturerZoetis Inc.Parnell Technologies Pty LtdIntervet Inc.
Active IngredientGonadorelin hydrochlorideGonadorelin acetateGonadorelin acetate
For Estrous Synchrony, Use With:LUTALYSE (dinoprost tromethamine)Cloprostenol sodiumESTRUMATE (cloprostenol injection)
Species/ClassLactating dairy cows Lactating dairy cows and beef cows  Lactating dairy cows

Other than the three uses listed in the table above, it is illegal to use GnRH products with another drug for estrous synchrony.

By prescribing FDA-approved GONABREED, you’re choosing one of the three marketed GnRH products shown to be safe and effective for use with another drug for synchronizing estrous cycles in lactating dairy cows. Also, GONABREED is the only marketed GnRH product shown to be safe and effective for use with another drug for synchronizing estrous cycles in beef cows. Used together in a breeding program, GONABREED and cloprostenol synchronize estrous cycles to allow for fixed time artificial insemination in lactating dairy cows 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 CVM's Education & Outreach Staff at 240-402-7002 or AskCVM@fda.hhs.gov.

Sincerely,

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

Page Last Updated: 04/24/2015
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