Application Nr Approved Date Route Status External Links
ANDA201680 2011-09-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Felbamate Tablets, Usp Are Not Indicated As A First Line Antiepileptic Treatment (see Warnings ). Felbamate Tablets, Usp Are Recommended For Use Only In Those Patients Who Respond Inadequately To Alternative Treatments And Whose Epilepsy Is So Severe That A Substantial Risk Of Aplastic Anemia And/or Liver Failure Is Deemed Acceptable In Light Of The Benefits Conferred By Its Use. If These Criteria Are Met And The Patient Has Been Fully Advised Of The Risk, And Has Provided Written Acknowledgment, Felbamate Tablets, Usp Can Be Considered For Either Monotherapy Or Adjunctive Therapy In The Treatment Of Partial Seizures, With And Without Generalization, In Adults With Epilepsy And As Adjunctive Therapy In The Treatment Of Partial And Generalized Seizures Associated With Lennox-Gastaut Syndrome In Children.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Felbamate FELBAMATE ZINC1530803

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