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  1. CVM Updates

FDA Approves First Generic Phenylpropanolamine Hydrochloride Chewable Tablets for Use in Dogs

June 11, 2024

Today the U.S. Food and Drug Administration approved Phenylpropanolamine Hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. This is the first generic phenylpropanolamine hydrochloride chewable tablets for dogs.

Urinary incontinence happens when a dog loses its ability to control when it urinates. Urinary incontinence due to urethral sphincter hypotonus can happen as dogs age and as the dog’s muscle in its urethra (the body part that leads from the dog’s bladder to outside its body) weakens and loses control over its ability to hold urine. 

Phenylpropanolamine Hydrochloride chewable tablets contain the same active ingredient (phenylpropanolamine hydrochloride) in the same concentration and dosage form as the approved brand name drug product, Proin chewable tablets, which were first approved on August 4, 2011. In addition, the FDA determined that Phenylpropanolamine Hydrochloride chewable tablets contain no inactive ingredients that may significantly affect the bioavailability of the active ingredient.

Phenylpropanolamine Hydrochloride chewable tablets are only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to diagnose the cause of urinary incontinence and to determine whether Phenylpropanolamine Hydrochloride chewable tablets are an appropriate treatment.

Phenylpropanolamine Hydrochloride chewable tablets are available in 25, 50 and 75 mg, in 60 and 180 count bottles. Phenylpropanolamine Hydrochloride chewable tablets are scored, and dosage should be calculated in half-tablet increments. Phenylpropanolamine Hydrochloride chewable tablets should be administered orally at a total daily dose of 2 mg/kg (0.91 mg/lb) of body weight twice daily, using a suitable combination of half-tablet increments. 

The application is sponsored by ZyVet Animal Health, Inc. based in Pennington, New Jersey.

For more information:

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

 
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