ZORYVE (roflumilast) is a Arcutis Biotherapeutics Inc. program in Atopic dermatitis, infants 3-24 months. Its PDUFA date is Feb 23, 2027, the FDA's goal date to complete review of the application. 3 FDA decisions on record below. Every date links its source.
Indications under review: Atopic dermatitis, infants 3-24 months; Plaque Psoriasis in Children Ages 2 to 5. Sponsor: Arcutis Biotherapeutics Inc. (ARQT). Market-cap tier at the time we tracked it: Mid. We track 4 catalyst events for this program: 1 upcoming and 3 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is ZORYVE (roflumilast)'s next FDA decision or readout?
ZORYVE (roflumilast)'s PDUFA date is Feb 23, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at ZORYVE (roflumilast)'s most recent FDA decision?
On Jun 29, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is ZORYVE (roflumilast) used for?
In our records ZORYVE (roflumilast) is under review or in development for Atopic dermatitis, infants 3-24 months; Plaque Psoriasis in Children Ages 2 to 5.
Who makes ZORYVE (roflumilast)?
Arcutis Biotherapeutics Inc. (ARQT).
Has ZORYVE (roflumilast) been approved by the FDA?
Yes. The FDA approved an application for ZORYVE (roflumilast) on Jun 29, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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