Vivus will be resubmitting an application to the FDA for the approval of its weight loss drug, Qnexa in the fourth quarter of this year. Vivus hopes that the new application will be approved so they can market the drug as a weight loss treatment for people who are no longer able to bear children.
The main reason Qnexa was refused in October by the FDA (Food and Drug Administration) in the US, was down to the possible risk of birth defects due to evidence surrounding birth defects in children born of women who had in the past taken Topiramate, one of the two active ingredients in Qnexa. Vivus will be carrying out a retrospective study on this in order to quash the concerns of the agency.
The application to market the drug to those who cannot bear children is likely to have a positive outcome according to analysts.