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NDA to be Filed for Odanacatib for Treatment of Osteoporosis in 2016 Pending Long Safety Review

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Additional Information

Additional Relevant Details Merck announced in its 10k SEC filing that it plans to file an NDA for odanacatib in 2016 following completion of blind extension study and an  independent re-adjudication of major adverse cardiovascular events (MACE).  In 2014, results were released on a Phase 3 study of odanacatib, however FDA filings were delayed based on safety concerns.  Depending upon the safety studies that will complete later this year, a NDA may be file for odanacatib by the end of the year.
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Related Keywords Nda Filing, Odanacatib, Osteoporosis, Cardiovascular Safety, Mk-0822