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

Novan (NOVN)Novan2023-01-06 08:00 ESTFDA / regulatory

- Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and under standard review timelines -

- Molluscum contagiosum is a viral skin infection that affects approximately 6 million people, most of them children1,2...

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.

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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

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

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

Novan

Recent company news

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

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