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🏅 FDA Orphan Designation

Cystadane

BETAINE

Manufacturer: Recordati Rare Diseases

Indicated for:
HomocystinuriaOrphanHomocystinuria due to cystathionine beta-synthase deficiencyHomocystinuria due to methylene tetrahydrofolate reductase deficiencyNeurodegeneration due to 3-hydroxyisobutyryl-CoA hydrolase deficiency

FDA-Approved Indications (4)

HomocystinuriaOrphan Designation

Treatment of homocystinuria to decrease elevated homocysteine blood levels.

indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations

Population: pediatric and adult patients

indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations

Population: pediatric and adult patients

indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations

Population: pediatric and adult patients

Indications & Usage

1 INDICATIONS AND USAGE CYSTADANE ® is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect CYSTADANE is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. Included within the category of homocystinuria are ( 1 ): Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect

💙 Support Programs

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Cystadane
Recordati
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Betaine Anhydrous
Eton Pharmaceuticals, Inc.
Betaine
Recordati
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Betaine Anhydrous
Eton Pharmaceuticals, Inc.

Where shown, WAC (Wholesale Acquisition Cost) is an estimate only — your actual cost depends on your insurance plan. Always verify pricing with your pharmacy or insurer.

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.