FDA Approves First Generic Version of Anti-Anxiety Medicine for Dogs

BOCA RATON, FL, October 30, 2019 – Mizner Bioscience, LLC., today announced that they received the first US FDA approval for a therapeutically equivalent generic version of Elanco’s Clomicalm®, (Clomipramine Hydrochloride Tablets). Approved by the U.S. Food and Drug Administration (FDA) through the Abbreviated New Animal Drug Application (ANADA) pathway. Clomipramine Hydrochloride Tablets are used as part of the comprehensive behavioral management program to treat separation anxiety in dogs greater than six months of age.

Bob Edwards, Chief Executive Officer of Mizner Bioscience, commented, “We are excited to launch our first of many generic drugs for the animal space. Generic drugs have been part of the human health system for decades, helping to lower the cost of treatment significantly. FDA approved generic alternatives offer animal health professionals alternatives to costly medications making it more affordable for pet parents.”


Clomipramine Hydrochloride Tablets will be available immediately in 5mg, 20mg, 40mg, and 80mg.


About Mizner Bioscience


Mizner Bioscience is a specialty pharmaceutical committed to the development and distribution of generic drugs for the animal health market. The company was founded on a single principle – that most times, the simplest solution is also the best solution. Our focus is not necessarily on the development of new molecules, but instead on cost-reducing generic therapies and solutions. Whether that’s making them less expensive, easier to administer, faster to act, or simpler to understand, the goal is always the same – better compliance means more effective therapy, which means better clinical outcomes. Which means more wagging tails.


Trademarks referenced herein are the property of their respective owners.


SOURCE Mizner Bioscience, LLC

About Author