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Zydus Lifesciences Limited, via its wholly owned subsidiary ZyVet® Animal Health, has announced the launch of the first FDA-approved generic phenylpropanolamine hydrochloride tablets, marking a significant milestone in managing canine urinary incontinence. This new generic medication offers veterinary professionals and pet owners a cost-effective and clinically reliable option for treating urinary incontinence caused by urethral sphincter hypotonus in dogs—a condition frequently observed in spayed females and aging pets.
Key Highlights of the Launch
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ZyVet®'s phenylpropanolamine hydrochloride tablets are approved by the U.S. Food and Drug Administration, ensuring trusted clinical efficacy and safety standards.
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The medication treats urinary incontinence by managing urethral sphincter hypotonus, one of the primary causes of involuntary urine leakage in dogs.
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Available in multiple tablet strengths, the product supports precise and tailored dosing by veterinarians.
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This is the first FDA-approved generic chewable version of phenylpropanolamine hydrochloride for dogs, comparable to the previously established branded drug Proin, thus offering a more affordable treatment alternative without compromising quality.
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ZyVet® leverages over 70 years of pharmaceutical expertise from Zydus Lifesciences, combining research, development, manufacturing scale, and quality assurance to ensure high standards.
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Less than 20% of animal drugs currently have generic options, highlighting the importance of this affordability breakthrough for pet healthcare.
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Regular veterinary monitoring is essential due to possible side effects such as vomiting, hypertension, behavioral changes, and rare but serious risks including seizures and heart arrhythmias.
Understanding Canine Urinary Incontinence and Treatment Goals
Urinary incontinence in dogs is generally triggered by a weakening of the urethral sphincter muscle, medically termed urethral sphincter hypotonus. This condition leads to involuntary urine leakage, often causing distress for both pets and their owners. It is particularly prevalent in spayed females and older dogs, impacting their quality of life with embarrassing accidents.
Phenylpropanolamine hydrochloride is a sympathomimetic amine that stimulates the urethral sphincter muscle, helping restore bladder control. ZyVet®'s generic formulation provides dependable symptom relief and aims to enhance long-term adherence to treatment by being both effective and affordable. This ensures that more dogs can access essential care without cost being a barrier.
The Medication’s Features and Usage
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Formulation: Chewable tablets approved by the FDA, bioequivalent to Proin tablets.
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Dosage: Available in 25 mg, 50 mg, and 75 mg strengths, with dosage calculated in half-tablet increments.
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Administration: Oral dosing twice daily, with doses typically adjusted to 2 mg per kilogram of the dog's body weight.
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Prescription-only: Requires a licensed veterinarian's diagnosis and prescription to ensure safety and appropriateness of use.
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Safety Precautions: Not recommended for dogs with pre-existing heart issues or pregnant, lactating, or breeding dogs due to limited safety data in these populations.
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Veterinary Monitoring: Critical to monitor for side effects such as hypertension, behavioral changes (anxiety, aggression), and rare serious events like seizures or renal failure.
ZyVet®'s Commitment to Veterinary Care Innovation
With this launch, ZyVet® reinforces its leadership in bringing affordable generic options to veterinary medicine, addressing a substantial gap where less than one-fifth of FDA-approved animal drugs have generic versions. Backed by Zydus Lifesciences' global pharmaceutical capabilities, ZyVet® is spearheading innovation that breaks the traditional high-cost barriers associated with new veterinary drugs.
The new phenylpropanolamine hydrochloride tablets not only provide veterinary professionals a high-quality, cost-effective tool to enhance patient care but also support pet owners in managing their pets' health with confidence and affordability.
Conclusion
Zydus Lifesciences, through ZyVet® Animal Health, marks a ground-breaking achievement in animal healthcare by making the first FDA-approved generic treatment for canine urinary incontinence widely available. This launch offers a trusted, affordable, and effective solution that promises to improve life quality for countless aging and spayed female dogs suffering from urinary incontinence, while aligning with the commitment to accessible, compassionate veterinary care.
Source: Zydus Lifesciences Limited Press Release & Company disclosure to the Stock Exchanges
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