FDA accepts application for topical molluscum treatment. medtwitter FDA
The Food and Drug Administration has accepted a new drug application for berdazimer gel 10.3% for the treatment of molluscum contagiosum, the manufacturer If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.
Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated., a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years and 85.5% were White . Study participants were randomized to berdazimer gel 10.
The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.Lead image: Zay Nyi Nyi/Dreamstime
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