Mizner Bioscience, LLC., a specialty pharmaceutical committed to the development and distribution of generic drugs for the animal health market, announced that they received the first US Food and Drug Administration (FDA) approval for a therapeutically equivalent generic version of Elanco’s Clomicalm (clomipramine hydrochloride tablets).
The drug is approved by the US FDA through the Abbreviated New Animal Drug Application (ANADA) pathway. Clomipramine hydrochloride tablets are used as part of the comprehensive behavioral management programme to treat separation anxiety in dogs greater than six months of age.
“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,” said Bob Edwards, chief executive officer, Mizner Bioscience.
Clomipramine hydrochloride tablets will be available immediately in 5mg, 20mg, 40mg, and 80mg.-Pharma Biz