said it won't submit an application to the Food and Drug Administration regarding its Pregbalin drug before the end of 2002.
Pregbalin is designed to treat patients suffering from epilepsy, neuropathic pain and generalized anxiety disorders. The New York-based company said it plans to submit an application in Europe and the U.S. in March 2003.
"This short delay will allow us to amplify the submission with requested toxicological mechanistic studies. We are confident Pregabalin will meet all necessary testing requirements, and the additional studies, we believe, will enhance the review process and subsequent approval for the drug," the company said in a press release.Separately,
The Wall Street Journal
reported that the FDA told Pfizer to stop running a series of magazine ads that it said misleadingly suggested its cholesterol-lowering drug, Lipitor, was safer than competitors' products. It marks the fourth time the FDA has cited ads for Lipitor.
Pfizer's shares were recently down 2.1% at $31.25.