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  1. Product Safety Information

INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets - Veterinarians

Dear Veterinarian:

Three products are FDA-approved to control urinary incontinence in dogs:

  • INCURIN (estriol) Tablets;
  • PROIN (phenylpropanolamine hydrochloride) Chewable Tablets; and
  • PROIN ER (phenylpropanolamine hydrochloride extended-release) Tablets.

INCURIN is the first, and so far only, FDA-approved animal drug that contains estriol as the active ingredient. PROIN and PROIN ER are the only FDA-approved animal drugs that contain phenylpropanolamine as the active ingredient.

Manufactured by Intervet, Inc., INCURIN is a prescription drug available in 1 mg strength tablets [New Animal Drug Application (NADA) 141-325]. Manufactured by Pegasus Laboratories, Inc., PROIN and PROIN ER are also prescription drugs. PROIN is approved for twice daily administration and available in 25, 50, and 75 mg strength tablets (NADA 141-324). PROIN ER is approved for once daily administration and available in 18, 38, 74, and 145 mg strength tablets (NADA 141-517). Please refer to Animal Drugs @ FDA for more information about INCURIN, PROIN, and PROIN ER. FDA wants to remind you of the benefits of using approved drugs in your clinic.

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. The company must show that the drug can be consistently produced from batch to batch; and
  • The drug’s labeling is truthful, complete, and not misleading. The company must make sure that the labeling contains all necessary information to use the drug safely and effectively and includes the risks associated with the drug.

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 from batch to batch;
  • The drug’s labeling to make sure the information remains truthful, complete, and not misleading; and
  • The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.

FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring that 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,

FDA’s Center for Veterinary Medicine