NPS Postpones Preos Filing To Add Two-Year Data From PaTH Study
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
NPS postpones Preos NDA filing to add two-year data from PaTH study. Submission was originally slated for year-end 2004. Firm says two-year results have implications for use of the osteoporosis agent with Fosamax (alendronate)
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Further Preos NDA delay
NDA submission for NPS' human parathyroid hormone product Preos will be delayed, the firm announces Feb. 7. NPS and partner Nycomed are currently preparing the European application for the osteoporosis therapy, slated for submission in March. "Because U.S. requirements are more extensive, NPS will submit its NDA following the Nycomed submission as soon as it has electronically formatted all of the additional documentation necessary for a successful U.S. marketing application," NPS claims. Filing had been scheduled for year-end 2004, but NPS postponed submission to add second-year data from a comparative trial (1Pharmaceutical Approvals Monthly Dec. 1, 2004, p. 6)...
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