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Serdolect Approval Status

  • FDA approved: No
  • Brand name: Serdolect
  • Generic name: sertindole
  • Company: Lundbeck A/S
  • Treatment for: Schizophrenia

Serdolect (sertindole) is an antipsychotic drug for the treatment of schizophrenia without sedative effect and with placebo level extrapyramidal symptoms (EPS).

Development Status and FDA Approval Process for Serdolect

DateArticle
May 20, 2009Lundbeck provides update on NDA for Serdolect for the treatment of schizophrenia
Apr  8, 2009FDA Advisory Committee provides opinion on Serdolect for the treatment of schizophrenia
Sep 15, 2008Lundbeck Submits New Drug Application (NDA) for Serdolect in the US for the Treatment of Schizophrenia

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