Infantile Spasms
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-08-29FDA Approved: VIGABATRIN — Original Application (Hikma Pharmaceuticals USA Inc)
FDA approved Hikma's generic Vigabatrin under an Original Application (ANDA 213104). This notice confirms approval of a generic Vigabatrin p…
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FDA approval · 2022-08-08FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, LLC.
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FDA approval · 2022-06-22FDA Approved: VIGABATRIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves the original ANDA for Vigabatrin (Amneal Pharmaceuticals NY LLC) for the treatment of infantile spasms and refractory complex p…
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FDA approval · 2022-01-19FDA Approved: VIGABATRIN — Original Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved the original application for vigabatrin by Zydus Pharmaceuticals (USA) Inc.
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FDA approval · 2021-10-20FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Sabril (vigabatrin) by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2021-09-29FDA Approved: VIGABATRIN — Original Application (Aurobindo Pharma Limited)
FDA approved an original ANDA for Vigabatrin from Aurobindo Pharma Limited, enabling generic availability of the drug.
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CLINICAL_TRIALS trial_result · 2021-05-27Clinical Trial Update: A Novel Approach to Infantile Spasms [Phase 3]
Phase 3 trial concerning a novel approach to infantile spasms has been suspended.
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FDA approval · 2021-01-29FDA Approved: VIGABATRIN — Original Application (Dr. Reddys Laboratories Inc.,)
FDA approves Dr. Reddy's Laboratories' original ANDA for vigabatrin, the generic form of this anticonvulsant.
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FDA approval · 2021-01-26FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Vigabatrin from Actavis Pharma, Inc., indicating an approval action related to an update to the …
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FDA approval · 2021-01-26FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Vigabatrin for oral solution from Camber Pharmaceuticals as an original application, enabling a generic product for specified e…
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FDA approval · 2020-12-02FDA Approved: VIGABATRIN — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' original ANDA for vigabatrin (generic vigabatrin). This approval makes a generic version of vigabatrin ava…
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FDA approval · 2020-10-20FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC. The action updates the approv…
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FDA approval · 2020-10-02FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA granted a supplemental approval for Vigabatrin by Dr. Reddys Laboratories Inc., initiating a new regulatory action related to the produc…
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FDA approval · 2020-10-02FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)
FDA approved a supplemental application for Vigabatrin by Cipla USA, Inc., granting an additional approval under the ANDA for Vigabatrin, ty…
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FDA label_change · 2020-10-02FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for Vigabatrin from Par Health USA, LLC, resulting in updated labeling for the product.
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FDA approval · 2020-10-02FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, LLC. This action authorizes changes r…
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CLINICAL_TRIALS trial_result · 2020-07-23Clinical Trial Update: Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) [Phase 3]
Phase 3 open-label extension of cannabidiol (CBD) for infantile spasms completed with posted results.
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CLINICAL_TRIALS trial_result · 2020-07-23Clinical Trial Update: Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) [Phase 3]
Phase 3 trial update for cannabidiol (GWP42003-P) in infantile spasms has completed with posted results.
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FDA approval · 2020-04-17FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for Vigabatrin submitted by Par Health USA, LLC. This action updates the regulatory status for V…
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FDA approval · 2020-04-17FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for VIGADRONE (vigabatrin) from Upsher-Smith Laboratories, LLC.
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FDA approval · 2020-04-17FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories, marking an update to the product's approval status.
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FDA approval · 2020-04-17FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approves Amneal Pharmaceuticals NY LLC's supplemental application for Vigabatrin (ANDA210155). This action updates the approval for the …
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FDA approval · 2020-01-24FDA 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 · 2019-12-03FDA Approved: VIGABATRIN — Original Application (Cipla USA, Inc.)
FDA approved the original generic application for vigabatrin submitted by Cipla USA, establishing a generic version of the anticonvulsant.
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CLINICAL_TRIALS trial_result · 2019-11-18Clinical Trial Update: Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms [Phase 2, Phase 3]
Phase 2/3 trial comparing intravenous methylprednisolone to oral prednisolone in infants with infantile spasms.