Forest Laboratories, Inc. And Almirall SA Announces FDA's Extended Review Period For Aclidinium Bromide-Reuters

Reuters reported that Forest Laboratories, Inc. and Almirall, S.A. said a U.S. regulator has extended the review period for their inhaled drug that could be used to treat a certain type of lung disease. The U.S. Food and Drug Administration will require a three-month extension to complete its review of the data supporting the new drug application for the drug, known generically as aclidinium bromide, the companies said. The drug is used for the maintenance treatment of chronic obstructive pulmonary disease, a serious lung disease that makes breathing difficult and is often caused by cigarette smoking. No additional data has been requested by the agency to complete the review. FDA action is expected by July 2012