The FDA approval process for Dapsone 7.5% is currently underway.
The 5.0 version of Dapsone was submitted on 13/09/2021 and received approval on 07/06/2023. With annual addressable market sales exceeding US$17.5 million, as measured by IQVIA.
The 7.5% version of Dapsone was submitted on 15/04/2021. According to IQVIA, annual sales for this product have already surpassed US$206 million, indicating strong market potential.
Given these figures, it is reasonable to anticipate FDA approval before the end of the financial year.
Please note that the above statement does not constitute professional advice. Please DYOR
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- Ann: Launch of Dapsone 5%, Gel in the United States
Ann: Launch of Dapsone 5%, Gel in the United States, page-31
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