Sunday, May 27, 2012

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

On April 20, 2012, the U.S. Food and Drug Administration (FDA) approvedf INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets to control urinary incontinence in dogs. The FDA noted:

By prescribing FDA-approved INCURIN and PROIN, you provide your clients and their dogs with the only marketed estriol and phenylpropanolamine products shown to be safe and effective for controlling urinary incontinence in dogs. INCURIN and PROIN are also the only marketed estriol and phenylpropanolamine products that are manufactured to meet FDA’s strict standards for quality, purity, and potency.
Please be aware that estriol and phenylpropanolamine products should not be imported from other countries for use in animals. In addition, bulk estriol and phenylpropanolamine should not be used to compound animal drugs.

The FDA also reminded veterinarians about compounding other strengths or dosages of INCURIN AND PROIN: 

A compounded animal drug is not FDA-approved. This means FDA has not evaluated the safety and effectiveness of the compounded drug or the adequacy of the manufacturing process. 

You may have specific patients that need estriol or phenylpropanolamine in strengths or dosage forms not offered by INCURIN or PROIN. In these limited cases, estriol or phenylpropanolamine can be legally compounded by using FDA-approved INCURIN or PROIN as the source of the active pharmaceutical ingredient. Please find additional requirements for legal animal drug compounding at Title 21, Code of Federal Regulations, Section 530.13.
To read entire FDA notice, click here.


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