In July we reported that the presiding Administrative Law Judge recommended issuing an exclusion order blocking the importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection). Since that time, the parties have submitted lengthy Petitions for Review and answered questions raised by the Commissioners. Now, the Commission has ruled….
We previously reported on an International Trade Commission hearing in a trade secret dispute brought by Allergan and Medytox against Daewoong and Evolus. In the underlying investigation, Allergan and Medytox seek to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection). A one-page public notice provides…
Last week, Evolus, Inc. announced updates to the regulatory progress of its BLA for DWP-450 (prabotulinumtoxinA), a follow-on biologic to Allergan’s Botox (onabotulinumtoxinA injection) product. Evolus reported that FDA issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical Co. Ltd., Evolus’s contract manufacturer for DWP-450. According to Evolus, the EIR confirmed the…