Infantile Spasms
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS withdrawal · 2019-11-14Clinical Trial Update: Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms [Phase 3]
Phase 3 trial comparing prednisolone to vigabatrin for first-line treatment of infantile spasms has been withdrawn.
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FDA approval · 2019-09-12FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC, typically resulting in updates to lab…
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FDA approval · 2019-09-12FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2019-09-12FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma's supplemental application for Vigabatrin, updating the existing approval for the drug.
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FDA approval · 2019-09-12FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin submitted by Dr. Reddy's Laboratories Inc., enabling continued availability of the ge…
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FDA approval · 2019-07-31FDA 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 · 2019-07-31FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approves a supplemental application for Sabril (vigabatrin) by Lundbeck Pharmaceuticals LLC, resulting in changes to the product's label…
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FDA label_change · 2019-05-31FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for SABRIL (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC, resulting in a labeling chang…
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FDA approval · 2019-05-31FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC. The action completes an approved suppleme…
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FDA approval · 2019-05-30FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Vigabatrin filed by Par Health USA, LLC.
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FDA approval · 2019-05-30FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories Inc., marking an approval related to a generic Vigabatr…
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CLINICAL_TRIALS trial_result · 2019-01-15Clinical Trial Update: Addition of Pyridoxine to Prednisolone in Infantile Spasms [Phase 3]
Phase 3 trial evaluating adding pyridoxine to prednisolone for infantile spasms has completed.
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FDA approval · 2019-01-14FDA Approved: VIGABATRIN — Original Application (Actavis Pharma, Inc.)
FDA page documents Actavis Pharma's original application for a generic Vigabatrin product, seeking approval to market a generic version.
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FDA approval · 2018-11-20FDA Approved: VIGABATRIN — Original Application (Dr. Reddys Laboratories Inc.,)
FDA approved the original abbreviated new drug application for Vigabatrin (generic) manufactured by Dr. Reddys Laboratories Inc.
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CLINICAL_TRIALS trial_result · 2018-09-19Clinical Trial Update: Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms [Phase 2]
Phase 2 clinical trial update for cannabidiol oral solution in the treatment of refractory infantile spasms; study terminated with results p…
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FDA approval · 2018-08-21FDA 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 approval · 2018-08-21FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for SABRIL (vigabatrin) by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2018-06-21FDA Approved: VIGADRONE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved the original generic application for Vigabatrin under the brand VIGADRONE by Upsher-Smith Laboratories, expanding access to the…
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CLINICAL_TRIALS trial_result · 2018-04-24Clinical Trial Update: Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy [NA]
Completed acceptability study evaluating a new pediatric formulation of vigabatrin for infants with infantile spasms or drug-resistant focal…
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FDA approval · 2018-03-13FDA Approved: VIGABATRIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal's generic version of vigabatrin under an Original Application (ANDA 210155), enabling marketing of the drug for its esta…
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CLINICAL_TRIALS trial_result · 2017-11-07Clinical Trial Update: Evaluation of Neuroinflammation in Children With Infantile Spasms [Phase 4]
A Phase 4 clinical trial evaluating neuroinflammation in children with infantile spasms has completed.
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FDA approval · 2017-04-27FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC.
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FDA approval · 2017-04-27FDA Approved: VIGABATRIN — Original Application (Par Health USA, LLC)
FDA approves Vigabatrin original Abbreviated New Drug Application for Par Health USA, LLC (generic entry).
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CLINICAL_TRIALS trial_result · 2016-08-31Clinical Trial Update: Molecular Genetics in Infantile Spasms
A clinical trial investigating molecular genetics in infantile spasms (West Syndrome) has completed.
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CLINICAL_TRIALS research · 2016-07-29Clinical Trial Update: Sabril Patient Registry
The Sabril patient registry update relates to vigabatrin use in infantile spasms and refractory complex partial seizures in adults, and the …