Collagenex Periostat additional preclinicals requested by FDA for NDA submission -- IPO.
Executive Summary
COLLAGENEX PERIOSTAT ADDITIONAL PRECLINICAL TRIALS REQUESTED BY FDA in preparation for an NDA submission for the doxycycline agent for treatment of periodontitis, the company states in an initial public offering prospectus. Collagenex expects to file the NDA for Periostat in 1996. "FDA requested that the company conduct additional animal studies regarding certain effects associated with the long-term dosing of doxycycline," the prospectus states. These studies are under way. "In addition, a post-approval, post-marketing animal study related to long-term dosing of doxycycline also was requested," the prospectus adds.