U.S. FDA delays decision on Ipsen drug to year end

Tue Sep 30, 2008 2:28am EDT
 
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LONDON, Sept 30 (Reuters) - French drugmaker Ipsen (IPN.PA) said on Tuesday the U.S. Food and Drug Administration would not now complete its first-cycle review of its new drug Dysport until the end of the year.

But the company said the FDA had not requested additional safety or clinical studies and the regulatory decision would not impact the anticipated launch plan timing.

Dysport is a botulinum toxin of type A for the treatment of patients with cervical dystonia. The FDA had been due to give ts decision on the product by Monday, but this date has now been put back until Dec. 28.

It is the latest in a series of delays in decisions at the U.S. agency. (Reporting by Ben Hirschler)

 

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