Pozen, Inc. (POZN) Plans to Submit Response to Approvable Letter For Trexima(TM) Within the Next Ten Days
10/5/2007 7:49:14 AM
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN) announced today that it plans to submit a response to the Approvable letter for Trexima received on August 1, 2007, within the next ten days. This action comes after POZEN and GlaxoSmithKline met jointly with the U.S. Food and Drug Administration (FDA) to discuss the proposed plan for responding to the Approvable letter.
POZEN believes the submission will constitute a full response. The submission will include clarifying non-clinical information to further address the agency’s concern regarding the genotoxic potential of Trexima and, as required by FDA, a routine clinical safety update. The FDA may take up to six months to review this submission, although POZEN will request an expedited review.