News »November 2006

Acomplia has been put on hold regarding its Approval by FDA

November 23, 2006

FDA {Food and drug Administration} of the U.S has decided to put Acomplia on a much slower track, and is yet to decide as to when to approve the sale of the drug in the United States, it is now set to be out only next Spring.

The FDA has postponed the release of the drug from two months to six months.

The tea leaves include:

Sanofi was not informed by FDA as to whether Acomplia resubmission would go through a Class 1{two –month} or Class 2{six- month} review. Sanofi in the meantime has issued press releases carrying good reports about Acomplia made by tiny Sweden and Mexico. It has been stated that Sanofi would not report any good news had it not received any about Acopmplia’s prospects in the market.

FDA published an all new meeting schedule for its advisory for its advisory panels for the rest of the year. It had no meeting scheduled for the Endocrinologic and Metabolic Drugs Advisory Committee – though the expert body will be asked to weigh the positive aspects and the negative aspects of Acomplia, keeping in mind the safety of the usage of the diet pill.

The FDA has also stated and has asked the expert panels to find out whether the antibiotic Ketek should be allowed to remain on the U.S. market after the reports of liver failure in many patients. The FDA is still to approve a number of drugs for various safety precautions. A two day meeting will be held on Dec. 14 and 15 on Ketek.

The U.S Senate Finance Committee is investigating allegations of fraud which is connected with the Ketek clinical trials. Sanofi- Aventis is the pharmaceutical company that manufactures Ketek, which is another drug being manufactured by them. A number of questions regarding its side effects and safety have been raised in the market.

Thus even the release of Acomplia, the diet pill in the United States is expected only by the middle part of 2007. FDA is still silent about its decision regarding the diet pill Acomplia.