Infantile Spasms
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CLINICAL_TRIALS research · 2025-05-08Clinical Trial Update: A Study to Prevent Infantile Spasms Relapse [Phase 2]
A Phase 2 clinical trial sponsored by the University of California, Los Angeles aims to prevent relapse of infantile spasms/West syndrome. T…
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CLINICAL_TRIALS research · 2025-02-11Clinical Trial Update: Characterization by Automated System on Infantile Spasmes
This ClinicalTrials.gov entry describes an ongoing study conducted by Assistance Publique - Hôpitaux de Paris to characterize infantile spas…
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FDA label_change · 2024-12-17FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)
FDA granted a supplemental approval for Vigabatrin by Actavis Pharma, Inc., updating the product under the ANDA process.
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FDA approval · 2024-12-17FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approves a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC.
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CLINICAL_TRIALS trial_result · 2024-09-19Clinical Trial Update: Tricaprilin Infantile Spasms Pilot Study [Phase 1]
The Phase 1 pilot trial of tricaprilin for infantile spasms has completed.
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FDA label_change · 2024-09-12FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for Sabril (vigabatrin) by Lundbeck Pharmaceuticals LLC, resulting in a label change to reflect …
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Novadoz Pharmaceuticals LLC)
FDA approved a supplemental application for Vigabatrin by Novadoz Pharmaceuticals LLC. This action represents regulatory approval of an upda…
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Vigabatrin by Ascend Laboratories, LLC. The approval updates the regulatory status for Vigabatri…
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Carnegie Pharmaceuticals LLC)
FDA approved a supplemental application for Vigabatrin filed by Carnegie Pharmaceuticals LLC.
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application to add Aurobindo Pharma Limited as an approved manufacturer of Vigabatrin.
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FDA approval · 2024-09-12FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC. The approval updates the product …
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories Inc. (ANDA 211481).
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC to market a generic Vigabatrin product.
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s supplemental application for Vigabatrin (ANDA 209822).
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FDA approval · 2024-09-12FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for VIGADRONE (vigabatrin) by Upsher-Smith Laboratories, LLC under ANDA 210196.
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)
FDA approves a supplemental application for vigabatrin submitted by Cipla USA, Inc. The approval updates the drug's labeling and/or indicati…
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Vigabatrin from Aurobindo Pharma Limited under an ANDA, granting approval for a generic form of …
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FDA approval · 2024-09-12FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application to Camber Pharmaceuticals for Vigabatrin for oral solution, enabling a generic oral form of Vigabatr…
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FDA approval · 2024-09-12FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, confirming an approved supplement to …
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CLINICAL_TRIALS research · 2024-06-25Clinical Trial Update: Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome [Phase 2, Phase 3]
A Phase 2/3 clinical trial compares ketogenic diet to ACTH for the treatment of West syndrome (infantile spasms) in children; the study is a…
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FDA approval · 2024-06-17FDA Approved: VIGAFYDE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approves VIGAFYDE (vigabatrin) from Upsher-Smith in an original NDA; the product is indicated for certain seizure disorders, including i…
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FDA approval · 2023-10-11FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Vigabatrin by Par Health USA, LLC.
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FDA approval · 2023-06-29FDA Approved: VIGADRONE — Original Application (Upsher-Smith Laboratories, LLC)
The FDA approved Upsher-Smith Laboratories' original application for Vigadrone (vigabatrin), a generic form of the anticonvulsant vigabatrin…
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CLINICAL_TRIALS trial_result · 2023-06-07Clinical Trial Update: A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms [Phase 3]
A Phase 3 trial evaluating cannabidiol oral solution with vigabatrin as initial therapy for infantile spasms has been terminated; results we…
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CLINICAL_TRIALS trial_result · 2023-06-02Clinical Trial Update: Open-label Extension to Protocol 1042-0500 [Phase 2]
An open-label extension to Protocol 1042-0500 (Phase 2) in infantile spasms was terminated. Results from the extension were posted in 2023.