FDA accepts Novan’s NDA for berdazimer 10.3% topical gel for the treatment of molluscum contagiosum

Noven Pharmaceuticals

7 March 2023 - FDA completes filing review of application with no filing issues identified.

Novan today announced that the US FDA accepted for filing Novan’s new drug application seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum. 

The Company also received its PDUFA goal date of 5 January 2024.

Read Noven Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier