Forest Laboratories, Almirall receive feedback from FDA regarding fixed dose combination of aclidinium/formoterol

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Apr 9 2014

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Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM:MC) today announced that they have recently received feedback from the U.S. Food and Drug Administration (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 (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 (Chronic Obstructive Pulmonary Disease) patients.

Source:

Forest Laboratories

Posted in: Drug Trial News | Disease/Infection News

Tags: Chronic, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Dermatology, Fibrosis, Food, Gastroenterology, Manufacturing, Muscle, Nervous System, Pain, Placebo, Respiratory

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