Forest Laboratories and Almirall, S.A. announced that they will delay the planned Q4 submission of a New Drug Application for the combination of aclidinium bromide, a long acting muscarinic antagonist and formoterol fumarate, a long acting beta agonist, for the indication of Chronic Obstructive Pulmonary Disease. This decision was based on comments provided by the FDA at a recent pre-NDA meeting. The delay is related to resolving chemistry, manufacturing and control specifications associated with the combination formulation. Forest and Almirall 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. The decision to delay the NDA filing for the combination does not affect the Tudorza monotheraphy product, the companies said.
- Forest Laboratories