Vivus's slimming drug has limited approval

Source: China Council for the promotion of drugs compilation on May 4, 2011, after qnexa was blocked from FDA approval, vivus said it had developed a plan to make its weight-loss drug qnexa approved in the near future - but this method will make the market of qnexa smaller than expected To remove regulatory barriers that prevent qnexa from reaching the mass market, developers said they had reached a consensus with the U.S Food and drug administration to design a retrospective study to identify one of the effective ingredients of qnexa as a potential threat to pregnant women from appetite suppressants Vivus, based in mountain view, California, outlined the status of qnexa's filing in its quarterly report, noting that an agreement had been reached with the FDA to resubmit qnexa's listing applications for overweight men and women who have passed their childbearing years Restricting the use of drugs to relieve regulators' safety concerns, but the market for middle-aged and elderly obese people is far from reaching the heavyweight bomb level Vivus added that it would decide whether to pursue more limited approvals after proposing a retrospective study schedule The resubmission of the application will require a six-month review process and pass the review at the CGE meeting Regulators are concerned that topiramate, one of the two main components of qnexa, may cause a variety of congenital defects in newborns, including cleft palate Therefore, vivus painstakingly launched a retrospective study protocol, and planned to use the existing data to compare with the experimental data of qnexa's neonatal exposure group and children's arm exposure group The news that limited approval applications are due to be resubmitted in the fourth quarter kept vivus's share price high Vivus reduced its quarterly loss to $9.9 million, down from $18.8 million in the first quarter of 2010 　　http://www.fiercebiotech.com/story/vivus-eyes-path-limited-approval-obesity-drug/ 2011-05-03