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🏅 FDA Orphan Designation

Ingrezza

valbenazine

Manufacturer: Neurocrine Biosciences Inc.

Indicated for:
Huntington diseaseOrphanParoxysmal dyskinesiaPulmonary arterial hypertension associated with another disease
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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 (3)

Huntington diseaseOrphan Designation

treatment of adults with chorea associated with Huntington's disease

indicated for the treatment of adults with tardive dyskinesia

Population: adults

indicated for the treatment of adults with chorea associated with Huntington's disease

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )] . - chorea associated with Huntington’s disease [see Clinical Studies ( 14.2 )] . INGREZZA and INGREZZA SPRINKLE are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated for the treatment of adults with: - tardive dyskinesia. ( 1 ) - chorea associated with Huntington’s disease. ( 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.