Forest Laboratories and Almirall have announced that a planned 4th quarter 2013 NDA submission for their aclidinium bromide/formoterol dry powder inhaler will be delayed due to the need to address FDA concerns regarding chemistry, manufacturing and control (CMC) specifications. The companies said that they “are working with the FDA regarding the CMC related comments provided at the pre-NDA meeting to determine the appropriate next steps, and expects to provide an update when more information becomes available.”
In May 2013, Forest and Almirall anounced positive Phase 3 results from a trial of the product for the treatment of COPD and said that they would be filing the NDA by the end of the year. That announcement followed soon after an announcement of positive Phase 3 results from another study.
Read the Forest and Almirall press release.
