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Forest Labs Reveal FDA Sought Extension To Review NDA For Aclidinium Bromide

Forest Laboratories Inc (FRX) along with international pharmaceutical company Almirall SA, on Thursday announced that the US Food and Drug Administration, or the FDA, had intimated to the company that it would require an additional three months to complete its review of the data supporting the New Drug Application for aclidinium bromide.

The companies reiterated that the FDA did not request for any additional data regarding the new drug application to complete its review.

The company stated that aclidinium bromide is the drug which would act as a new long-acting antimuscarinic for the maintenance treatment of Chronic Obstructive Pulmonary Disease, or COPD.

The efficacy and safety of aclidinium was studied in a clinical trial program including 2,717 COPD patients in 9 studies. In these trials, aclidinium demonstrated significant improvement in lung function, with a low incidence of side effects, comparable to placebo.

by RTT Staff Writer

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