Application Nr Approved Date Route Status External Links
NDA020241 1994-12-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Lamictal Is An Antiepileptic Drug (aed) Indicated For: Epilepsy—adjunctive Therapy In Patients ≥2 Years Of Age: (1.1) Partial Seizures. Primary Generalized Tonic-Clonic Seizures. Generalized Seizures Of Lennox-Gastaut Syndrome. Epilepsy—monotherapy In Patients ≥16 Years Of Age: Conversion To Monotherapy In Patients With Partial Seizures Who Are Receiving Treatment With Carbamazepine, Phenobarbital, Phenytoin, Primidone, Or Valproate As The Single Aed. (1.1) Bipolar Disorder In Patients ≥18 Years Of Age: Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes In Patients Treated For Acute Mood Episodes With Standard Therapy. (1.2) 1.1 Epilepsy Adjunctive Therapy: Lamictal Is Indicated As Adjunctive Therapy For The Following Seizure Types In Patients ≥2 Years Of Age: Partial Seizures. Primary Generalized Tonic-Clonic Seizures. Generalized Seizures Of Lennox-Gastaut Syndrome. Monotherapy: Lamictal Is Indicated For Conversion To Monotherapy In Adults (≥16 Years Of Age) With Partial Seizures Who Are Receiving Treatment With Carbamazepine, Phenytoin, Phenobarbital, Primidone, Or Valproate As The Single Antiepileptic Drug (aed). Safety And Effectiveness Of Lamictal Have Not Been Established (1) As Initial Monotherapy; (2) For Conversion To Monotherapy From Aeds Other Than Carbamazepine, Phenytoin, Phenobarbital, Primidone, Or Valproate; Or (3) For Simultaneous Conversion To Monotherapy From 2 Or More Concomitant Aeds. 1.2 Bipolar Disorder Lamictal Is Indicated For The Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes (depression, Mania, Hypomania, Mixed Episodes) In Adults (≥18 Years Of Age) Treated For Acute Mood Episodes With Standard Therapy. The Effectiveness Of Lamictal In The Acute Treatment Of Mood Episodes Has Not Been Established. The Effectiveness Of Lamictal As Maintenance Treatment Was Established In 2 Placebo-Controlled Trials In Patients With Bipolar I Disorder As Defined By Dsm-Iv [see Clinical Studies (14.2)]. The Physician Who Elects To Prescribe Lamictal For Periods Extending Beyond 16 Weeks Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lamotrigine LAMOTRIGINE ZINC13156

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