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🏅 FDA Orphan Designation

Topamax

Topiramate

Manufacturer: Johnson & Johnson Pharmaceutical R & D, LLC

Indicated for:
Lennox-Gastaut syndromeOrphanEating reflex epilepsyEpilepsy with generalized tonic-clonic seizures alone

FDA-Approved Indications (3)

Lennox-Gastaut syndromeOrphan Designation

As adjunctive therapy in patients two years and older with siezures associated with Lennox-Gastaut syndrome.

initial monotherapy for the treatment of partial-onset seizures in patients 2 years of age and older

Population: pediatric ≥2 years

initial monotherapy for the treatment of primary generalized tonic-clonic seizures in patients 2 years of age and older

Population: pediatric ≥2 years

Indications & Usage

1 INDICATIONS AND USAGE TOPAMAX is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy TOPAMAX is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy TOPAMAX is indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. 1.3 Migraine TOPAMAX is indicated for the preventive treatment of migraine in patients 12 years of age and older.

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Topiramate
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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.