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🏅 FDA Orphan Designation

Fintepla

fenfluramine

Manufacturer: UCB, Inc.

Indicated for:
Lennox-Gastaut syndromeOrphanDravet syndrome
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (2)

Lennox-Gastaut syndromeOrphan Designation

Treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older

FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older

Population: pediatric ≥2 years

Indications & Usage

1 INDICATIONS AND USAGE FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. ( 1 )

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.