FDA filing of aclidinium bromide/formoterol fumarate delayed.
Forest Laboratories, and Almirall will delay the planned fourth quarter 2013 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.
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