FDA Expands Pediatric Roflumilast Use - Scorecard - MDSpire
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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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Clinical Scorecard: FDA Expands Pediatric Roflumilast Use

At a Glance

CategoryDetail
ConditionPlaque Psoriasis
Key MechanismsTopical phosphodiesterase type 4 inhibitor
Target PopulationPediatric patients aged 2 years and older
Care SettingDermatology

Key Highlights

  • Roflumilast cream 0.3% approved for pediatric use in plaque psoriasis.
  • Previously approved for adults and children aged 6 years and older at a 0.15% dose.
  • Approval based on pharmacokinetics, safety, and efficacy data from pediatric studies.
  • Topical steroids not recommended for sensitive areas or long-term use in children.

Guideline-Based Recommendations

Diagnosis

  • Diagnosis of plaque psoriasis in pediatric patients aged 2 years and older.

Management

  • Use roflumilast cream 0.3% as a topical treatment for plaque psoriasis.

Monitoring & Follow-up

  • Monitor for common adverse reactions including diarrhea, headache, and application-site pain.

Risks

  • Contraindicated in patients with moderate to severe liver impairment.

Patient & Prescribing Data

Pediatric patients aged 2 years and older with plaque psoriasis.

Roflumilast cream 0.3% is safe and well tolerated in children.

Clinical Best Practices

    Related Resources & Content

    Original Source(s)

    FDA Expands Pediatric Roflumilast Use

    • by Kathryn Wighton

    • June 30, 2026

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