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Kindred Biosciences seeks US FDA approval for Zimeta to treat pyrexia in horses
San Francisco, California | Monday, February 15, 2016, 10:00 Hrs  [IST]

Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, announced the submission to FDA of the Effectiveness Technical Section of the New Animal Drug Application (NADA) for Zimeta (dipyrone injection, KIND-012).

Positive topline results from the pivotal field study (KB0120) of Zimeta for the control of pyrexia (fever) in horses were recently reported by the company.

The Chemistry, Manufacturing, and Controls technical section for Zimeta was submitted in December 2015 and all remaining technical sections of the NADA are planned for submission by the end of the first quarter of 2016.

Richard Chin, CEO of KindredBio, stated, “We are pleased to bring Zimeta one step closer to approval. We believe that with its favourable safety profile in horses, Zimeta will offer an attractive first-in-class therapy for an important unmet medical need.”

Peter R. Morresey, BVSc, MACVSc, Dipl. ACVIM, Dipl. ACT of Rood and Riddle Equine Hospital in Lexington, Kentucky stated, “Dipyrone will be very familiar to seasoned veterinarians. While never approved in the United States, dipyrone enjoyed widespread usage for control of fever and pain before withdrawal from the market in 1995. Since that time, it has continued to be widely used successfully in other countries. If approved, it will be available again in the United States, in an FDA-approved formulation, a new generation of veterinarians and horses can benefit from dipyrone's proven fever-controlling properties.”

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