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From Earlier: Forest and Almirall Announce Positive FDA Advisory Committee's Recommendation for Approval of Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease

Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. announced yesterday that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted 12 to 2 in favor of approving the New Drug Application for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of COPD. The Committee was also asked to separately evaluate if the efficacy and safety of the 400 ug twice daily dose had been adequately demonstrated. The members voted unanimously in favor of efficacy and 10 to 3 (1 member abstained) in favor of safety.

Today's committee recommendations, although not binding, will be considered by the FDA as it completes its review of the NDA for aclidinium bromide. Forest and Almirall anticipate receiving FDA feedback on the filing in the second quarter of calendar year 2012.

Posted-In: News FDA

 

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