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US Health Panel to Review Acomplia in June

US panel of health experts will review anti-obesity pill Acomplia in June, said Sanofi-Aventis, the pharmaceutical firm developing it. However, analysts are up in arms stating the move has caused new concerns over its approval by the Food and Drug Administration (FDA) for its marketing in the US.

Karl Heinz Koch, analyst at Vontobel, slamming FDA said that the panel meeting reflects that there are many issues that need to be address.

Defending her firm's stand, Sanofi-Aventis spokeswoman said the Endocrinologic and Metabolic Drugs Advisory Committee meeting, which will be held on June 13, to discuss the safety and efficacy of Acomplia, will not affect FDA's marketing decision expected for July 26.

Raising doubts over the meeting, some analysts said it could improve the chances of it winning a diabetes label.

Acomplia is a new drug that works by blocking the cannabinoid type 1 receptor in the brain to diminish urges for food.

According to clinical trials, Acomplia has been effective in shedding weight, reducing waist size, improves cholesterol and blood sugar levels in type 2 diabetics and it reduces the level of fats in the blood.

Though, the trails have also shown many patients leaving the treatment midway because of its various side-effects like nausea, anxiety and depression.

Accepting the effectiveness of the drug, Koch quizzed that is efficacy enough to get the nod over its safety issues without specialists input?

Various European and Latin American countries prescribes Acomplia, but the US health regulator on many occasions had delayed Sanofi marketing decision to launch its drug in the US around a year ago.

Acomplia has won European Union approval as a complementary to diet and exercise to treat overweight patients, who suffer from type 2 diabetes and abnormal levels of fat in the blood. Where as it is being reimbursed in six EU nations.

 
 
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