Lennox-gastaut Syndrome
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FDA approval · 2016-05-16FDA Approved: RUFINAMIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a generic version of Rufinamide for the treatment of seizures associated with Lennox-Gastaut syndrome, under Hikma Pharmace…
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CLINICAL_TRIALS research · 2016-05-04Clinical Trial Update: European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS)
The European Registry of Anti-Epileptic Drug Use in Lennox-Gastaut Syndrome has completed enrollment and data collection for the registry.
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FDA approval · 2015-12-14FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)
FDA approved Eisai's supplemental application for FYCOMPA (perampanel) to update the labeling and potentially expand its approved uses for e…
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FDA approval · 2015-11-04FDA Approved: FELBAMATE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved the original application for a generic felbamate product from ANI Pharmaceuticals, Inc.
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FDA approval · 2015-10-06FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approved a supplemental application for BANZEL (rufinamide) by Eisai Inc.
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FDA approval · 2015-06-25FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.
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FDA approval · 2015-06-25FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approved a supplemental application for BANZEL (rufinamide) from Eisai Inc.
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FDA approval · 2015-02-12FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approves a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.
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FDA approval · 2015-02-12FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.
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FDA approval · 2014-12-09FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC. The approval updates the labeling for ONFI, p…
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FDA approval · 2014-12-09FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Onfi (clobazam) by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2014-01-16FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2013-11-21FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) filed by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2013-11-21FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for ONFI (clobazam) by Lundbeck Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2013-11-21Clinical Trial Update: A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) [Phase 3]
Phase 3 placebo-controlled study of E2080 in Lennox-Gastaut Syndrome has completed with results posted in 2013.
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FDA approval · 2013-06-06FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.
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CLINICAL_TRIALS trial_result · 2013-05-06Clinical Trial Update: Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome [Phase 3]
Open-label Phase 3 study evaluating the safety and effectiveness of clobazam in Lennox-Gastaut Syndrome.
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FDA approval · 2012-12-14FDA Approved: ONFI — Original Application (Lundbeck Pharmaceuticals LLC)
The FDA approved ONFI (clobazam) through an original NDA for use as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome …
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FDA approval · 2012-10-25FDA Approved: CLONAZEPAM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for clonazepam from Aurobindo Pharma Limited under an ANDA, confirming continued availability of thi…
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FDA label_change · 2012-08-31FDA Approved: FELBAMATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for felbamate submitted by Mylan Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2012-02-09Clinical Trial Update: Clobazam in Patients With Lennox-Gastaut Syndrome [Phase 3]
Phase 3 clinical trial results for clobazam in Lennox-Gastaut syndrome; the study is completed and results were posted in 2012.
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CLINICAL_TRIALS trial_result · 2012-02-09Clinical Trial Update: Clobazam in Subjects With Lennox-Gastaut Syndrome [Phase 2]
A Phase 2 trial evaluating clobazam in Lennox-Gastaut syndrome completed, with results posted in 2012.
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FDA approval · 2011-07-06FDA Approved: FELBAMATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Felbamate submitted by Mylan Pharmaceuticals Inc., updating the approved use of Felbamate un…
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FDA approval · 2011-06-10FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc., resulting in updated labeling and/or indication…
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FDA approval · 2011-06-10FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.