IRVINE, Calif.--(BUSINESS WIRE)--Allergan, Inc. (NYSE: AGN) commented today on Ipsen’s and Medicis’s joint announcement that the U.S. Food and Drug Administration (FDA) has conditioned its approval of DYSPORT® (abobotulinumtoxinA) for the treatment of cervical dystonia and glabellar lines on their commitment to adopt a Risk Evaluation and Mitigation Strategies (REMS) program. The companies report in their news release that one of the purposes of the FDA-mandated REMS is to mitigate the significant risks such as medication errors and overdosing that may result from treating different botulinum toxins as interchangeable. For instance, DYSPORT® is not interchangeable or substitutable for BOTOX® or BOTOX® Cosmetic (collectively, BOTOX®). Additionally Ipsen has announced that the FDA has required that the DYSPORT® package insert contain a “boxed warning” regarding the potential spread of DYSPORT® distant from the site of injection, and to address this in their REMS program.
