Eprontia FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 8, 2021.
FDA Approved: Yes (First approved November 5, 2021)
Brand name: Eprontia
Generic name: topiramate
Dosage form: Oral Solution
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Epilepsy, Migraine Prevention
Eprontia (topiramate) is a ready-to-use liquid formulation of the approved anticonvulsant topiramate for use in the treatment of epilepsy and the preventive treatment of migraine.
- Eprontia is indicated for the treatment of:
- Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; 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
- Preventive treatment of migraine in patients 12 years of age and older
- Eprontia oral solution is usually administered twice daily without regard to meals. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately.
- Common adverse reactions reported in epilepsy patients include paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever. Common adverse reactions reported in migraine patients include paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.
Development timeline for Eprontia
|Nov 8, 2021||Approval FDA Approves Eprontia (topiramate) Oral Solution for Epilepsy and Preventive Treatment of Migraine|
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