FDA Expands Pediatric Roflumilast Use - Takeaways - MDSpire

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

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  • 1

    The FDA has approved roflumilast (ZORYVE) cream 0.3% for treating plaque psoriasis in pediatric patients aged 2 years and older.

  • 2

    Roflumilast was previously approved for adults and children aged 6 years and older at a lower 0.15% dose.

  • 3

    The approval was based on a study evaluating pharmacokinetics, safety, and efficacy in children aged 2 to 5 years.

  • 4

    Roflumilast cream is contraindicated in patients with moderate to severe liver impairment.

  • 5

    Common adverse reactions in trials included diarrhea, headache, insomnia, and application-site pain.

Original Source(s)

FDA Expands Pediatric Roflumilast Use

  • by Kathryn Wighton

  • June 30, 2026

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