ARQT PDUFA Date: ZORYVE Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Feb 23, 2027 · Arcutis · Atopic dermatitis, infants 3-24 months
Key facts FDA PDUFA target date 2027-02-23
Drug / candidate ZORYVE (roflumilast)
Indication Atopic dermatitis, infants 3-24 months
Company Arcutis
Market-cap tier Mid
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → FAQ When is the ARQT PDUFA date? The FDA PDUFA target date for ARQT (Arcutis) is 2027-02-23 for ZORYVE (roflumilast). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is ARQT's drug ZORYVE? ZORYVE (roflumilast) is Arcutis's candidate under FDA review for Atopic dermatitis, infants 3-24 months.
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