FDA Expands Pediatric Roflumilast Use

The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.

By
Kathryn Wighton
June 30, 2026
3 min

MDSpire News

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The FDA has approved roflumilast (ZORYVE) cream 0.3% for treating plaque psoriasis in pediatric patients aged 2 years and older.
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Roflumilast was previously approved for adults and children aged 6 years and older at a lower 0.15% dose.
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The approval was based on a study evaluating pharmacokinetics, safety, and efficacy in children aged 2 to 5 years.
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Roflumilast cream is contraindicated in patients with moderate to severe liver impairment.
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Common adverse reactions in trials included diarrhea, headache, insomnia, and application-site pain.

FDA Expands Pediatric Roflumilast Use

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Original Source(s)

FDA Expands Pediatric Roflumilast Use

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