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news.The FDA has accepted for review NPS Pharmaceutical's new drug application to market Preos for the treatment of osteoporosis in postmenopausal women.
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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.