FDA accepts NDA for berdazimer gel, 10.3% ,for the treatment of molluscum contagiosum with a PDUFA goal date of 5 January 2024- Novan Inc.
Novan, Inc. announced that the FDA accepted for filing Novan’s New Drug Application (“NDA”) seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum .The Company also received its Prescription Drug User Fee (“PDUFA”) goal date of January 5, 2024.
“ 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.”
Ms. Brown Stafford continued, “In early 2022, we acquired marketed dermatology products and a commercial team with product launch expertise. Novan’s commercial infrastructure includes a highly experienced sales and marketing team, supply chain capabilities, market access knowledge, medical affairs experts, and a network of related partners. We believe this not only differentiates Novan in a meaningful way, but also provides the fundamental capabilities to position us for a successful launch and revenue growth following the potential approval of berdazimer gel, 10.3%.”
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