FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5
Arcutis Biotherapeutics, Inc. - Common stock (ARQT)
Company Research
Source: GlobeNewswire
ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well toleratedOnce-daily, steroid-free cream can be used anywhere on the body for any durationAbout 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S.Sixth FDA approval for ZORYVE in just over three yearsCommercial product expected to be available by the end of October 2025 WESTLAKE VILLAGE, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company dedicated to developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for ZORYVE® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age. Once-daily ZORYVE cream 0.05% provides rapid and significant clearance
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News
- Arcutis Biotherapeutics: Behind The Big Rally [Seeking Alpha]Seeking Alpha
- Arcutis Biotherapeutics (NASDAQ:ARQT) was given a new $37.00 price target on by analysts at Mizuho.MarketBeat
- Tori Spelling And Daughter Stella Open Up About Struggles With Eczema [Forbes]Forbes
- FDA Accepts Supplemental New Drug Application for Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children Ages 2 to 5GlobeNewswire
- Arcutis Completes Enrollment in INTEGUMENT-INFANT Phase 2 Study Evaluating ZORYVE® (roflumilast) Cream 0.05% in Infants with Atopic Dermatitis [Yahoo! Finance]Yahoo! Finance
ARQT
Earnings
- 10/28/25 - Beat
ARQT
Sec Filings
- 12/3/25 - Form 4
- 12/3/25 - Form 4
- 12/1/25 - Form 144
- ARQT's page on the SEC website