Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

Forest Laboratories Inc (FRX: Quote) 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.

Click here to receive FREE breaking news email alerts for Forest Laboratories Inc and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Stocks moved notably higher over the course of the trading day on Friday after initially showing a lack of direction. The gains on the day extended the recent upward trend by the markets, with the tech-heavy Nasdaq reaching its best closing level in almost a month. Looking to capitalize on news of an Ebola diagnosis in New York City, Republican Senate candidate Scott Brown issued a statement Friday criticizing his Democratic opponent Sen. Jeanne Shaheen, D-N.H., for "waffling" on a travel ban. In another troubling sign for Democrats, the results of a Gallup poll released on Friday show that Tea Party Republicans are much more motivated to vote in the upcoming midterm elections than other Americans. The poll found that 73 percent of Tea Party Republicans are "extremely" or "very" motivated to vote in this year's elections.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.