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See Latest ArticlesKing Provides Additional Information on the REMOXY NDA Resubmission Plan
King Pharmaceuticals, 07/08/09
King Pharmaceuticals, Inc. announced additional information regarding the resubmission plan for the REMOXY New Drug Application. The Company is not required by the Food and Drug Administration to conduct clinical trials in order to provide additional safety or efficacy data in patients with moderate to severe chronic pain. However, as part of the resubmission plan, and in order to strengthen the NDA, King plans to conduct a likeability study and a pharmacokinetic trial in volunteers.
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