FDA approves new estrous-synchronization product

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Several gonadorelin (GnRH) products are approved and available for treating cystic ovaries in dairy cows, but until recently, none were FDA-approved for use in combination with another drug for synchronizing estrous cycles in lactating dairy and beef cattle.

Now the FDA has approved GONAbreed, a sterile injectable solution of gonadorelin acetate from Parnell Technologies, for use in combination with cloprostenol for synchronizing estrous cycles to allow for fixed time artificial insemination.

Daniel G. McChesney, Ph.D, director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine, posted a letter to veterinarians this week describing the product, its approved use and the approval process.

McChesney notes that FDA rigorously evaluates animal drugs prior to approval. 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.

For more information on GONAbreed, read McChesney’s letter on the FDA website.



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