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FDA Reconsiders Weight Loss Drug Qnexa Thu Nov 10, 2011 6:30 am
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FDA Reconsiders Weight Loss Drug Qnexa


Nov. 9, 2011 -- The FDA is again considering approval of an experimental weight loss drug it rejected a year ago over concerns about potential heart problems and birth defects in babies born to women who take the drug.

California-based pharmaceutical company Vivus Inc, is now asking for limited approval for its oral combination drug Qnexa, which would exclude women in their childbearing years.

According to the company, the FDA is scheduled to make an approval decision next April. If approved, the drug could be commercially available soon after that.

That would make Qnexa the only prescription appetite suppressant approved for long-term use available in the U.S. The only other widely marketed prescription weight loss drug, orlistat -- sold by prescription as Xenical and over-the-counter as Alli -- works by blocking dietary fat absorption.

In a study submitted to the FDA last year in Vivus’ original filing, and published in the journal Obesity late last week, people who took the highest dosage of Qnexa for a year lost, on average, about 14% of their body weight. They showed improvements in blood pressure, cholesterol, triglycerides, and blood sugar.

http://www.webmd.com/diet/news/20111108/fda-reconsiders-weight-loss-drug-qnexa?src=RSS_PUBLIC
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FDA Reconsiders Weight Loss Drug Qnexa Thu Nov 10, 2011 6:30 am
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