FDA Accepts Arcutis' Supplemental New Drug Application For Roflumilast Cream 0.15% For The Treatment Of Atopic Dermatitis In Adults And Children Down To Age 6
Portfolio Pulse from Benzinga Newsdesk
The FDA has accepted Arcutis Biotherapeutics' supplemental New Drug Application for Roflumilast Cream 0.15% to treat atopic dermatitis in adults and children aged 6 and above. This acceptance indicates a regulatory milestone for Arcutis, potentially expanding the use of Roflumilast Cream beyond its current indications.
November 29, 2023 | 1:04 pm
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Arcutis Biotherapeutics' stock may see a positive short-term impact as the FDA's acceptance of the sNDA for Roflumilast Cream could lead to expanded treatment indications and potentially increased market share.
The FDA's acceptance of Arcutis' sNDA is a positive development, signaling regulatory progress and potential for increased revenue if the application leads to approval for the expanded indication. This news is likely to be viewed favorably by investors, as it represents growth potential for the company's product portfolio.
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