Ipsen Release: FDA Issues Complete Response Letter to Ipsen for Dysport(R) Biologics License Application

PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Paris:IPN) today announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport®. The application, submitted by the Group in late 2007, seeks approval to market Dysport® for the treatment of cervical dystonia. The Group is now actively preparing to launch the product, once approved by the FDA, and as soon as reimbursement coverage is adequate.
MORE ON THIS TOPIC