News » September 2006

No comments from Sanofi or FDA regarding Acomplia approval in US

September 22, 2006

Even after acomplia launch in UK and Germany there is no reply from sanofi or even from FDA about its approval in US. Also none of the both has disclosed the reasons for which FDA is not approving or delaying it for US.

We still remember the grand introduction of acomplia when it was first launched in UK three months ago after getting approval from EMEA. The big boom adjectives and promising facts can still be seen in the news papers but it seems very strange when the same got very silent entrance in Germany.

This news has eradicated the problem from FDA but no doubt increased the concern of regulators for the pill as after so much publicity every overweight or obese person want to use it to get rid of the extra pounds and this pill is meant for only those people who are badly obese and are a prediabetic patients

It is also not confirmed if the pill is available in Denmark or not as sanofi has said that they have plans to launch the drug on 15th of September after the prices have been set by Danish regulators. Sanofi officers are also not replying to any queries also and hence not giving any information.

However the price for acomplia drug in Denmark is set to be 108.50 Euros which is $138.22 US dollars for a month. The price set in Denmark is higher then the one set for UK. Drug could be available for sale in Denmark soon. Next countries in the queue are Ireland, Norway, and Finland where acomplia is expected to be launched.

Side effects of Acomplia are also a matter of concern and most of the spectators have the opinion that FDA should be given more rights regarding the advertising of new drugs. It is also being said that FDA will not act on acomplia issue until an independent panel will get satisfy with its safety issues. The advisory meeting is also no looking to be held soon as mentioned in the new updated calendar of FDA advisory meetings.