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🏅 FDA Orphan Designation

Betaine Anhydrous

BETAINE ANHYDROUS

Manufacturer: Eton Pharmaceuticals, Inc.

Indicated for:
HomocystinuriaHomocystinuria due to cystathionine beta-synthase deficiencyHomocystinuria due to methylene tetrahydrofolate reductase deficiency

FDA-Approved Indications (3)

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 in pediatric and adult patients

Population: pediatric and adult patients

indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients

Population: pediatric and adult patients

Indications & Usage

1. INDICATIONS AND USAGE Betaine Anhydrous for Oral Solution 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 Betaine Anhydrous for Oral Solution 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: • Cystathionine beta-synthase (CBS) deficiency • 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency • Cobalamin cofactor metabolism (cbl) defect

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Betaine Anhydrous
Eton Pharmaceuticals, Inc.
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.