FDA Will Review Acomplia April 26
"On Friday, Sanofi announced that the FDA has set April 26 as the new date to review Acomplia and give Sanofi a thumbs-up or -down on marketing it in the U.S. Back in February, the drug received an approvable letter for its weight-loss indication and was deemed non-approvable as a treatment to help people stop smoking.
Acomplia was approved in the European Union back in late June, but the U.S. is where the big money is, especially now that France and Germany have been enacting new measures such as higher taxes on drug sales and rules to encourage doctors to prescribe cheaper prescriptions or generic drugs.
Since the limited launch of the drug in the EU in the third quarter, Acomplia sales have been roughly $15 million. But sales should increase much faster as Sanofi gets the word out about Acomplia via marketing and other measures."
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