Lennox-gastaut Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-07-31FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approves a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, expanding its labeling to reflect additional …
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FDA approval · 2020-04-16FDA Approved: RUFINAMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Rufinamide (Hikma Pharmaceuticals USA Inc.) under ANDA204988, signaling an approved addition…
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FDA approval · 2020-02-24FDA Approved: CLOBAZAM — Original Application (NorthStar RxLLC)
The FDA approved CLOBAZAM (clobazam) from NorthStar RxLLC through an original abbreviated new drug application. This marks the entry of a ge…
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FDA approval · 2019-11-28FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approves a supplemental application for BANZEL (rufinamide) from Eisai Inc.
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FDA approval · 2019-11-28FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc. for use in Lennox-Gastaut syndrome.
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FDA approval · 2019-09-06FDA Approved: CLOBAZAM — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' CLOBAZAM (clobazam) as an original generic application, authorizing a generic version of the drug. The app…
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FDA approval · 2019-05-31FDA Approved: FELBAMATE — Original Application (Novitium Pharma LLC)
FDA approved an Original Application for felbamate by Novitium Pharma LLC, enabling a generic felbamate product for seizure disorders. The p…
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FDA approval · 2019-05-22FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, updating the labeling to reflect the new …
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FDA approval · 2019-04-23FDA Approved: RUFINAMIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approval of a generic Rufinamide (ANDA 207363) for seizures associated with Lennox-Gastaut syndrome, enabling generic access.
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FDA approval · 2019-04-23FDA Approved: RUFINAMIDE — Original Application (Bionpharma Inc.)
The FDA approved an original application for a generic version of Rufinamide by Bionpharma Inc. for use in treating seizures associated with…
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FDA approval · 2019-04-15FDA Approved: CLOBAZAM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA approves CLOBAZAM as an original ANDA for a generic clobazam product from Taro Pharmaceuticals U.S.A., Inc.
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FDA approval · 2019-01-30FDA Approved: CLOBAZAM — Original Application (Micro Labs Limited)
The FDA approved Micro Labs Limited's generic CLOBAZAM (clobazam) under Original Application ANDA211711.
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FDA approval · 2018-12-12FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Epidiolex (cannabidiol) submitted by Jazz Pharmaceuticals, Inc. The action updates the produ…
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FDA approval · 2018-11-01FDA Approved: SYMPAZAN — Original Application (Aquestive Therapeutics)
The FDA approved SYMPAZAN (clobazam) via an Original Application from Aquestive Therapeutics.
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FDA approval · 2018-10-22FDA Approved: CLOBAZAM — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved an original ANDA for CLOBAZAM from Amneal Pharmaceuticals NY LLC, authorizing the generic version of clobazam.
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FDA approval · 2018-10-22FDA Approved: CLOBAZAM — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved the original application for CLOBAZAM (clobazam) from Upsher-Smith Laboratories, LLC, as a generic anticonvulsant product. The …
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FDA approval · 2018-10-22FDA Approved: CLOBAZAM — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals' original ANDA for CLOBAZAM (clobazam), enabling the generic version of the epilepsy medication to b…
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FDA approval · 2018-10-22FDA Approved: CLOBAZAM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA approved CLOBAZAM (clobazam) through an Original Abbreviated New Drug Application for Taro Pharmaceuticals U.S.A., Inc., representing a …
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FDA approval · 2018-10-22FDA Approved: CLOBAZAM — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' generic clobazam (CLOBAZAM) under an original ANDA.
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FDA approval · 2018-10-22FDA Approved: CLOBAZAM — Original Application (Bionpharma Inc.)
FDA approves CLOBAZAM as a generic clobazam product via an Original Application (ANDA) for Bionpharma Inc.; submission status is AP.
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FDA approval · 2018-06-25FDA Approved: EPIDIOLEX — Original Application (Jazz Pharmaceuticals, Inc.)
FDA approved Epidiolex (cannabidiol) under its original application for treating seizures in Lennox-Gastaut syndrome and Dravet syndrome. Th…
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FDA approval · 2018-06-15FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC. The approval updates the drug's l…
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FDA approval · 2018-06-15FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA has approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2017-06-16FDA Approved: FELBAMATE — Original Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA approved the original application for Felbamate, authorizing its generic marketing in the United States by Taro Pharmaceuticals U.S.A., …
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FDA approval · 2017-05-30FDA Approved: FELBAMATE — Original Application (Zydus Lifesciences Limited)
FDA approved Felbamate from Zydus Lifesciences Limited under an Original Application (ANDA).