FDA delays approval of Requip in extended release form
LONDON The Food and Drug Administration has delayed the approval of an extended release version of the GlaxoSmithKline Parkinson’s disease drug, Requip, according to published reports.
The FDA, though, did offer the company a conditional approval, which means that the agency requires certain conditions be satisfied before the drug can obtain final marketing approval. Those conditions though were not released publicly.
Requip XL, would be a once-daily formation of Requip, which is usually taken three times daily. According to drugpatentwatch.com, Requip had sales of over $260 million in the U.S. in 2006.
Currently, Requip XL has been approved in eight European countries, and is expected to be launched in an additional 17 markets by the first quarter of 2008.
Court overturns $3 million jury award against Wyeth’s Prempro
PHILADELPHIA A judge has overturned a jury’s decision to award a woman $3 million for claiming that Wyeth’s hormone-replacement drug Prempro caused her breast cancer, according to the Associated Press. The judge said the plaintiff did not have sufficient evidence to show that the company acted negligently.
Only four of about 1,500 cases pending in Philadelphia have gone to trial. Each time, a jury sided with the plaintiff only to have the judge reverse the verdict, lawyer Tobi Millrood said. The plaintiff, Jennie Nelson plans on appealing the decision to the state Superior Court.
Nelson had claimed that she was diagnosed in 2001 after taking the drug for five years to treat symptoms of menopause. Her lawyers argued that the manufacturer Wyeth had knowledge the drug caused cancer, yet failed to issue adequate warnings.
This is in contrast to a recent decision in Nevada that saw Wyeth lose a verdict to three women who made the same claims. The women won $134 million in that case.
Sun Pharma, Novartis reach agreement on Exelon
MUMBAI, India Sun Pharmaceuticals and Novartis have reached an out-of-court settlement in relation to Novartis’ Alzheimer’s drug Exelon, according to published reports.
“Under the terms of the settlement, Sun Pharma will not market generic Exelon in the U.S. until sometime prior to the expiration of the patents covering Exelon. The specific date on which Sun may launch and the other terms of the agreement are confidential,” said Sun Pharma in a statement.
Sun Pharma, being one of the first to file an application to sell generic Exelon in the U.S, was eligible to share a 180-day marketing exclusivity on the drug. However, had it launched its generic version of Exelon before reaching an agreement with Novartis, it would have done so at risk of damage claims by Novartis for patent infringement.
Exelon had sales of about $200 million last year in the U.S.