U.S. Food and Drug Administration (FDA) is going to take another three months for the approval of the diet drug Qnexa by Vivus Inc. It was announced that the drug will be approved by April 17 but the date has been changed and now it will be approved somewhere about July 17.
[hana-code-insert name=’StumbleUpon’ /][hana-code-insert name=’Reddit’ /]Vivus has reported that the extension will give the company more time to review the safety strategy for the drug.
“The Qnexa REMS (Risk Evaluation and Mitigation Strategy) submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February,” said Leland F. Wilson, chief executive officer of VIVUS. “We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans.”
On approval Qnexa will be the first drug in more than a decade to be approved for obesity control. It is actually made by the two medicines i.e. phenteramine, the appetite suppressant, and topiramate, anti-seizure medication.
It can help the users to lose 10% of their weight, if used in combination with diet and exercise. Moreover, it has also been found to be effective in decreasing diabetes, blood pressure and other cardiovascular risk factors.
Some have found its adverse effects such as increased heart rate and risk of cleft lip in newborns of pregnant women taking Qnexa.