NPS submitted the application on May 10, 2005, and the FDA has now made a threshold determination that the Preos NDA is sufficiently complete to permit a substantive review.
Clinical results in the application are based upon data from 13 separate studies including an international multi-center phase III trial of approximately 2,600 postmenopausal osteoporotic women.
A similar application to market Preos (parathyroid hormone) in Europe under the brand name Preotact is currently under review by the European Medicines Agency.