Merck Arcoxia user fee deadline
Executive Summary
User fee date for Merck's COX-2 inhibitor Arcoxia (etoricoxib) is Nov. 13, assuming FDA accepts the NDA for filing by March 12. Delay extends user fee deadline by two weeks; Merck told investors it submitted the Arcoxia NDA Dec. 30, but FDA now considers Jan. 13 the effective submission date...