FDA Accepts Novan NDA for Molluscum Contagiosum with PDUFA Goal Date of January 5, 2024

 – FDA completes filing review of application with no filing issues identified –

– New Chemical Entity (“NCE”) has potential to be the first FDA-approved prescription product for molluscum in the U.S. –

– Novan’s commercial team and sales force ready to prepare for launch of berdazimer gel, 10.3%, if approved –

Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today 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% (SB206) for the treatment of molluscum contagiosum (“molluscum”). The Company also received its Prescription Drug User Fee (“PDUFA”) goal date of January 5, 2024.

https://finance.yahoo.com/news/fda-accepts-novan-nda-berdazimer-130000318.html