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January 10, 2012
14:53 EDTFRXForest Labs expects FDA action for Aclidinium, Linaclotide
NDA for Aclidinium was filed as planned in mid-2011, and the company expects FDA action in Q2. NDA for Linaclotide was filed in mid-2011, and the company also expects FDA action to come in Q2. Comments and guidance were taken from slides for the J.P. Morgan Annual Healthcare Conference.
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April 17, 2014
16:08 EDTFRXActavis, Forest Labs receive second request under Hart-Scott-Rodino from FTC
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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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