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FDA Yet to be Convinced About Obesity Drug Qnexa
The FDA had earlier rejected the application for approval of the drug, Qnexa, back in October 2010 and had asked Vivus for additional information regarding its clinical trials.
However the agency is not satisfied with the information and believes that the drug could lead to health problems due to long term use and can also cause birth defects.
An advisory panel for the FDA will be meeting on February 22 to review two years worth of clinical data before deciding whether to recommend the agency to approve the drug or not. The FDA said that while the drug has demonstrated loss of weight in its users, concerns of birth defects and accelerated heartbeat still remains.
Source-Medindia
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