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UPDATE 1-FDA extends review period for Forest Lab lung drug
March 29, 2012 / 7:05 AM / 6 years ago

UPDATE 1-FDA extends review period for Forest Lab lung drug

March 29 (Reuters) - Forest Laboratories and Almirall 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.

COPD is the fourth-leading cause of death in the United States and affects about 24 million people, according to the American Lung Association.

No additional data has been requested by the agency to complete the review. FDA action is now expected by July 2012, the companies said.

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