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April 9, 2014
05:50 EDTFRXForest Labs reports FDA provided feedback on combination aclidinium, formoterol
Forest Laboratories announced that they have recently received feedback from the FDA regarding the fixed dose combination of aclidinium and formoterol. Although no new issues have arisen, further discussion is needed with the Agency in order to address questions related to CMC, or Chemistry, Manufacturing and Control, and a Type C meeting with the FDA is going to be requested, likely to be held during Q3 this year. Forest and Almirall believe that the fixed dose combination of aclidinium and formoterol can be an important therapy for U.S. COPD patients.
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