FDA Accepts Resubmitted BLA for Injection to Improve Frown Lines
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.
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