Issued: April 20, 2012
Reissued: February 25, 2016
In 2011, the U.S. Food and Drug Administration (FDA) approved both INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets to control urinary incontinence in dogs. INCURIN is the first, and so far only, FDA-approved animal drug that contains estriol as the active ingredient. PROIN is the first, and so far only, FDA-approved animal drug that contains phenylpropanolamine as the active ingredient. FDA wants to remind you of the benefits of using approved drugs in your clinic.
Manufactured by Intervet Inc., INCURIN (New Animal Drug Application 141-325) is a prescription drug available in 1 mg strength tablets. Manufactured by Pegasus Laboratories, Inc., PROIN (New Animal Drug Application 141-324) is also a prescription drug and is available in 25, 50, and 75 mg strength tablets. Please refer to the Freedom of Information Summaries and package inserts for INCURIN and PROIN for more information about each 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 not misleading.
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;
- The drug’s labeling to make sure the information remains truthful 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.
FDA’s Center for Veterinary Medicine