Top line results from phase III B-SIMPLE program of SB 206 for the treatment of molluscum contagiosum.- Novan Inc.
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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.
Novan, Inc. announced that the Company has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for berdazimer gel, 10.3% (SB 206) for the topical treatment of molluscum contagiosum (“molluscum”). Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval.
Novan, Inc. announced the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase III clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum in the peer-reviewed journal, JAMA Dermatology.