Forest and Almirall get FDA feedback on fixed dose combo of aclidinium and formoterol

9 April 2014

US drugmaker Forest Laboratories (NYSE: FRX) and partner Almirall (ALM: MC), Spain’s largest pharma company, say they have recently received feedback from the US Food and Drug Administration 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 (Chemistry, Manufacturing and Control) and a Type C meeting with the FDA is going to be requested, likely to be held during the third quarter of this year. Forest and Almirall believe that the fixed dose combination of aclidinium and formoterol can be an important therapy for US chronic obstructive pulmonary disease (COPD) patients.

NDA filing delayed last year

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