PARIS--(BUSINESS WIRE)--Regulatory News:
Ipsen (Paris:IPN) today announced that it has submitted a Biologics License Application (BLA) for Dysport® for Injection in cervical dystonia to the Food and Drug Administration (FDA) in the United States for the treatment of patients with cervical dystonia. In accordance with US regulations, the FDA will now be conducting a technical screening of the application to ensure that sufficient data and information have been submitted to justify the final review of the dossier by the Center for Drug Evaluation and Research.