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Aptiom Approval History

FDA Approved: Yes (First approved November 8, 2013)
Brand name: Aptiom
Generic name: eslicarbazepine acetate
Dosage form: Tablets
Previous Name: Stedesa
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Epilepsy, Seizures

Aptiom (eslicarbazepine acetate) is a voltage-gated sodium channel blocker for the treatment of partial-onset seizures in patients with epilepsy.

Development History and FDA Approval Process for Aptiom

DateArticle
Sep 14, 2017Approval Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
Aug 28, 2015Approval FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures
Nov  8, 2013Approval FDA Approves Aptiom to Treat Seizures in Adults
Mar  8, 2013Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy
May  4, 2010FDA Provides Complete Response to Sepracor's New Drug Application for Stedesa
Jan 29, 2010FDA Extends PDUFA Action Date for Stedesa New Drug Application
Jun  1, 2009Sepracor's Stedesa (eslicarbazepine acetate) New Drug Application Formally Accepted for Review by the FDA
Mar 31, 2009Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy

Further information

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