Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade FRX now with 

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
British manufacturing growth eased further in August to its lowest level in 14 months as output and demand increased at slower rates, survey results from Markit Economics showed Monday. The Markit/CIPS Purchasing Managers' Index dropped to 52.5 from a revised 54.8 in July. Economists had expected the score to fall to 55.1 from July's original figure of 55.4. Consumers spent less in July than in the previous month, a surprise retreat that complicates the prevailing belief that the U.S. economic situation is improving. Along with the unexpected drop in spending, government figures released on Friday showed that incomes rose at a slower pace in July than in the previous month. Meanwhile, data on prices indicated that inflation pressures remain tame. India's economy grew faster-than-expected in the three months to June and at the strongest pace in two years, preliminary figures from the Central Statistics Office revealed Friday. Gross domestic product grew 5.7 percent in the April to June quarter, which exceeded economists' forecast for 5.5 percent expansion. The economy grew 4.6 percent in the previous three months.
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.