Forest Laboratories Inc. (FRX) Tuesday said that Daliresp was approved by the U.S. Food and Drug Administration or FDA as a treatment to reduce the risk of chronic obstructive pulmonary disease or COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.
The efficacy and safety of Daliresp was evaluated in eight clinical studies including 9,394 adult patients. COPD is an under-diagnosed, progressive, irreversible lung disease.
Daliresp is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
"The introduction of Daliresp as an additional treatment option to reduce the risk of COPD exacerbations is an important development for patients with severe COPD associated with chronic bronchitis and a history of exacerbations," said Stephen Rennard, University of Nebraska Medical Center and clinical trial investigator.
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