Deprenyl Animal Health Inc. will be the first company toparticipate in a program that aims to harmonize the U.S andCanadian review process for new animal drugs.
The company (NASDAQ:DAHI), based in Overland Park, Kan., willsubmit a new animal drug application for the pharmaceuticaldeprenyl to both countries simultaneously and will have theapplications reviewed jointly by the U.S. Food and DrugAdministration and the Canadian Health Protection BranchBureau.
In the United States, deprenyl is marketed as an orphan drugfor treatment of late-stage Parkinson's disease in humans.Toronto-based Deprenyl Research Ltd. (NASDAQ:DEPLF), whichowns 40 percent of DAHI, is licensed to market deprenyl fortreatment of late-stage Parkinson's in Canada.
In October, DAHI will begin the equivalent of clinical trials inthe United States for the use of deprenyl to prevent age-related dysfunctions in dogs. Data from the trials will bereviewed jointly by U.S. and Canadian officials "to achievesome efficiencies in terms of investment of the time andresources spent on trials and the review process itself," saidDr. David Stevens, president of DAHI. -- Kris Herbst
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