2023-03-07 08:37:46 ET
- Dermatology drug developer Novan ( NASDAQ: NOVN ) announced Tuesday that the FDA accepted its New Drug Application (NDA) for berdazimer gel, 10.3%, as a treatment for viral infection, molluscum contagiosum.
- The agency has granted January 05, 2024, as the Prescription Drug User Fee (PDUFA) date for its decision. The company said that if approved, berdazimer gel is set to become the first FDA-cleared prescription product for molluscum.
- “The opportunity for our NDA to be approved in less than 10 months from today marks a significant and important milestone for Novan and its shareholders,” Chief Executive Paula Brown Stafford remarked.
- Announcing the NDA submission in January, Novan ( NOVN ) said that its marketing application is backed by data from its pivotal Phase 3 B-SIMPLE4 clinical study, which reached the primary endpoint indicating a favorable safety profile for berdazimer gel.
For further details see:
Novan anti-viral gel goes under FDA review