The Food and Drug Administration (FDA) has accepted the resubmission of Evolus’ Biologics License Application (BLA) for prabotulinumtoxinA (DWP-450) seeking approval for the treatment to temporarily improve the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
DWP-450 is an injectable formulation of a 900 kDa botulinum toxin Type A complex. The BLA resubmission was following the FDA’s Complete Response Letter (CRL) in May 2018 requesting additional data for completion of review; the deficiencies were regarding items related to Chemistry, Manufacturing, and Controls (CMC) processes.
The FDA has set a target Prescription Drug User Fee Act date of February 2, 2019. The Company stated it is on track to commercially launch the product in Spring 2019.
For more information visit Evolus.com.