logo
Share SHARE
FONT-SIZE Plus   Neg

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

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Electric car maker Tesla's Chief Elon Musk confirmed that there will be no discount on new cars. Through several tweets and an email addressing its employees, Musk said, "It is absolutely vital that we adhere to the no negotiation and no discount policy that has been true since we first started taking orders 10 years ago." Shares of National Beverage Corp. fell about 15 percent on Wednesday after short selling firm Glaucus Research Group has said it is shorting the soft-drink maker and accused the company of manipulating earnings. In a research report, Glaucus alleged that National Beverage achieved its "remarkable history of financial performance in part by manipulating earnings." Canadian pipeline operator Enbridge Inc. said it has agreed to sell its liquids pipeline assets in the South Prairie Region, including the Saskatchewan pipeline system, to privately-held midstream company Tundra Energy Marketing Ltd. for C$1.075 billion in cash.
comments powered by Disqus
Follow RTT