FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over

Arcutis Biotherapeutics

24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025.

Arcutis Biotherapeutics today announced the FDA has accepted its sNDA for Zoryve (roflumilast) foam 0.3%, a once daily, next generation phosphodiesterase-4 inhibitor, for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis.

Read Arcutis Biotherapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier