Ipsen: FDA's First-Cycle Review of Dysport(R) to Be Completed by Year-End
9/30/2008 8:40:58 AM
PARIS--(BUSINESS WIRE)--Regulatory News:
Ipsen (Paris:IPN) today announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport® (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008. This regulatory decision will not impact the anticipated company launch plan timing.