FDA Approves Generic Chewable Tablets for Dog Incontinence

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WASHINGTON, D.C. — The FDA on Tuesday approved phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence in dogs. This is the first generic version of these tablets, which are used to manage a condition known as urethral sphincter hypotonus, where the muscles controlling urination weaken.

Urinary incontinence in dogs occurs when they lose control over their urination. This can happen as dogs age and the muscle in the urethra, the tube that carries urine from the bladder to outside the body, weakens. This condition is particularly common in older dogs and can cause significant discomfort and hygiene issues.

The newly approved phenylpropanolamine hydrochloride chewable tablets contain the same active ingredient at the same concentration and dosage form as the brand-name drug Proin, first approved in 2011. These generic tablets offer a more affordable option for pet owners while maintaining the same efficacy and safety standards.

The FDA has confirmed that this generic version contains no inactive ingredients that would affect how the drug is absorbed by the dog’s body. This ensures that the generic tablets perform the same as the branded version.

These chewable tablets will be available by prescription only. A veterinarian’s expertise is essential to diagnose the cause of urinary incontinence and determine if phenylpropanolamine hydrochloride is the appropriate treatment.

The tablets come in dosages of 25, 50, and 75 mg and are sold in bottles of 60 and 180 counts. They are designed to be easily divided into half-tablet increments to provide precise dosing. The recommended dosage is 2 mg per kilogram of the dog’s body weight, administered twice daily.

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The application for the generic drug was sponsored by ZyVet Animal Health, Inc. based in Pennington, New Jersey.

This approval is significant for dog owners dealing with urinary incontinence in their pets. While it is a common issue, it can severely impact a dog’s quality of life. Effective management of this condition can help dogs lead more comfortable and hygienic lives.

Generic drugs play a crucial role in making healthcare more accessible. They offer the same benefits as their brand-name counterparts but at a lower cost. This is particularly important in veterinary medicine, where treatment costs can add up quickly.

For veterinarians, having access to an effective and affordable generic option provides more flexibility in treating their patients. It also underscores the importance of ongoing innovation and regulation in the pharmaceutical industry to ensure pets receive the best possible care.

In summary, the FDA’s approval of phenylpropanolamine hydrochloride chewable tablets marks a positive development in the treatment of canine urinary incontinence. It promises to improve the quality of life for many dogs and offers a cost-effective solution for pet owners.

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