Novan announces FDA accepted NA for berdazimer gel, 10.3%

Novan announced that the U.S. Food and Drug Administration, FDA, accepted for filing Novan’s New Drug Application, NDA, seeking approval for berdazimer gel, 10.3% for the treatment of molluscum contagiosum. The Company also received its Prescription Drug User Fee, PDUFA, goal date of January 5, 2024. "The opportunity for our NDA to be approved in less than 10 months from today marks a significant and important milestone for Novan and its shareholders. We believe our NCE can provide a much-needed therapeutic option for molluscum patients with the added benefit of being an easily applied, topical, self-administered treatment," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "We are thrilled that the FDA determined our application is sufficiently complete, no filing review issues were identified, and that the substantive review process has commenced."