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Thursday, October 25, 2018 11:27:38 AM
Bioanalytical samples and statistical analysis for such studies are pending. An update on the results will be provided once the analysis is complete.
The FDA granted our request for an extension to February 28, 2019 to resubmit our NDA for Oxycodone ER under section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. However, we plan to resubmit the application later this year.
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