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FDA Accepts Novan's NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum with a PDUFA Goal Date of January 5, 2024

Novan (NOVN)NovanFDA / regulatory

- 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...

Related news

NOVNNovan2023-01-06 08:00 EST

Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum

NOVNNovan2021-11-02 07:30 EST

Novan Appoints Brian M. Johnson as Chief Commercial Officer and Receives Conditional FDA Acceptance of Proposed Brand Name KINSOLUS™ for SB206 in Molluscum Contagiosum

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Novan

Novan was a dermatology-focused biotechnology company built around nitric oxide-based therapies for skin conditions and related inflammatory indications. Its story was centered on a narrow clinical platform and the challenge of turning topical science into a durable commercial path.

Recent company news

NOVNNovan2023-07-17 08:45 EST

Novan Enters into Agreement to Sell Substantially All of its Assets, including Berdazimer Gel, 10.3% (SB206), and Files for Chapter 11 Protection

NOVNNovan2023-06-05 09:00 EST

Novan to Provide Corporate Update at its 2023 Annual Meeting of Stockholders

NOVNNovan2023-05-31 16:05 EST

Novan Focuses Strategic Direction and Announces Restructuring

NOVNNovan2023-05-15 06:45 EST

Novan Reports First Quarter 2023 Financial Results and Provides Corporate Update

NOVNNovan2023-05-08 09:05 EST

Novan to Report First Quarter 2023 Financial Results on May 15, 2023

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Biopharma
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United States