Generic drug for urinary incontinence in dogs receives FDA approval

Officials with the FDA have approved the first generic phenylpropanolamine hydrochloride chewable tablets (Phenylpropanolamine Hydrochloride; ZyVet Animal Health, Inc) for the control of urinary incontinence because of urethral sphincter hypotonus in dogs. Phenylpropanolamine Hydrochloride chewable tablets contain the same active ingredient (phenylpropanolamine hydrochloride) in the same concentration and dosage form as Proin chewable tablets (PRN Pharmacal).¹

Urinary incontinence occurs when a dog loses its ability to control when it urinates. Urinary incontinence because of urethral sphincter hypotonus can happen as dogs age and as the animal’s muscle in its urethra weakens and loses control over its ability to hold urine.¹

ZyVet’s phenylpropanolamine hydrochloride chewable tablets are only available by prescription from a licensed veterinarian. Professional veterinary expertise is needed to diagnose the cause of urinary incontinence and to determine whether phenylpropanolamine hydrochloride chewable tablets are an appropriate treatment.¹

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. These generic 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.¹

Based in Pennington, New Jersey, ZyVet Animal Health Inc manufactures bioequivalent generic drugs for the animal health market. The company is a division of Zydus Lifesciences, a global generic pharmaceuticals developer for human medicine.²

Proin chewable tablets were first approved by the FDA on August 4, 2011, as a brand name drug product. ZyVet’s Phenylpropanolamine Hydrochloride chewable tablets contain no inactive ingredients that may significantly affect the bioavailability of the active ingredient.¹

References

1. FDA approves first generic phenylpropanolamine hydrochloride chewable tablets for use in dogs. FDA. June 11, 2024. Accessed June 12, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-phenylpropanolamine-hydrochloride-chewable-tablets-use-dogs?utm_medium=email&utm_source=govdelivery
2. About us. ZyVet Animal Health. Accessed June 12, 2024. https://zyvetusa.com/about-us/