Infantile Spasms

• FDA approval · 2016-06-21
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2015-11-03
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for SABRIL (vigabatrin) from Lundbeck Pharmaceuticals LLC.

• FDA label_change · 2015-09-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) filed by Lundbeck Pharmaceuticals LLC, resulting in updated labeling for the…

• FDA label_change · 2015-09-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA label_change · 2014-04-03
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

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• FDA label_change · 2013-10-26
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for SABRIL (vigabatrin) from Lundbeck Pharmaceuticals LLC, addressing changes to the product lab…

• CLINICAL_TRIALS trial_result · 2013-04-09
  Clinical Trial Update: Prednisolone in Infantile Spasms- High Dose Versus Usual Dose [Phase 3]

  Phase 3 trial comparing high-dose versus usual-dose prednisolone for infantile spasms (West syndrome) has completed. The document reports th…

• CLINICAL_TRIALS withdrawal · 2013-04-09
  Clinical Trial Update: Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy [Phase 2, Phase 3]

  The trial investigating the Modified Atkins Diet for infantile spasms refractory to hormonal therapy has been withdrawn from Phase 2 and Pha…

• FDA approval · 2012-12-11
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved Lundbeck's supplemental application for SABRIL (vigabatrin), updating the labeling per NDA020427. This approval reflects ch…

• FDA approval · 2012-12-11
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for SABRIL (vigabatrin) from Lundbeck Pharmaceuticals LLC. The action typically updates labeling or …

• CLINICAL_TRIALS withdrawal · 2012-09-13
  Clinical Trial Update: An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms [Phase 4]

  An open-label pharmacokinetic study of vigabatrin in infants with infantile spasms was conducted but later withdrawn.

• FDA approval · 2011-01-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2011-01-18
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• CLINICAL_TRIALS trial_result · 2010-11-22
  Clinical Trial Update: Use of the Modified Atkins Diet in Infantile Spasms [Phase 2, Phase 3]

  The document reports completion of Phase 2 and Phase 3 clinical investigations evaluating the Modified Atkins Diet for infantile spasms.

• CLINICAL_TRIALS trial_result · 2009-08-28
  Clinical Trial Update: Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study

  This randomized controlled trial compares a short-term ketogenic diet with conventional long-term therapy in children with refractory infant…

• FDA approval · 2009-08-21
  FDA Approved: SABRIL — Original Application (Lundbeck Pharmaceuticals LLC)

  FDA approved Sabril (vigabatrin) from Lundbeck as an original NDA for the treatment of infantile spasms and refractory complex partial seizu…

• FDA approval · 2009-08-21
  FDA Approved: SABRIL — Original Application (Lundbeck Pharmaceuticals LLC)

  FDA approved the original application for Sabril (vigabatrin), marking its initial authorization for infantile spasms.

• CLINICAL_TRIALS trial_result · 2008-03-04
  Clinical Trial Update: Metabolic Abnormalities in Children With Epilepsy

  The NINDS-sponsored clinical trial investigating metabolic abnormalities in children with epilepsy has completed.