Posted by Michael Wonder on 02 Aug 2018
Evolus announces early resubmission to the FDA of its biologics licence application for DWP-450
2 August 2018 - Commercial launch planned for spring 2019.
Evolus announced that today it is resubmitting its biologics license application for its lead product candidate, DWP-450 (prabotulinumtoxinA), to the U.S FDA.
The resubmission follows the receipt of a Complete Response Letter (“CRL”) from the FDA in May 2018 which necessitated the submission of additional data to the FDA for the completion of review of Evolus’ BLA. Deficiencies cited by the FDA in the CRL were isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. No deficiencies were related to clinical, non-clinical or safety matters.
