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🏅 FDA Orphan Designation

Copaxone

glatiramer acetate

Manufacturer: Teva Pharmaceuticals USA

Indicated for:
Pediatric multiple sclerosisOrphanNON RARE IN EUROPE: Multiple sclerosisNicolau 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 (3)

For reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, i

Population: adults

COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, i

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ).

💙 Support Programs

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GLATIRAMER ACETATE
Teva
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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.