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FDA Requests Additional Analyses and Supporting Information for Sumatriptan/Naproxen Sodium Agent
Provision of the additional information will allow the FDA to determine the comparability of the new data submitted in November to that contained within the original Trexima NDA and to more fully assess the relative safety profile of Trexima. POZEN expects to prepare and submit the revised response before year end.
Dr. Marshall Reese, executive vice president, product development of POZEN stated, "We appreciate this additional guidance from the FDA with respect to the information to be included in our complete response. Although there is no certainty that these revisions, coupled with the original data, will lead to the approval of the Trexima NDA, we continue to believe that the data for Trexima demonstrate superior efficacy and a safety profile comparable to sumatriptan."
Source: Pozen, Inc.