Lennox-gastaut Syndrome

• FDA approval · 2016-12-16
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC.

• FDA approval · 2016-12-16
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC, expanding the label for seizures associated w…

• FDA approval · 2016-05-16
  FDA Approved: RUFINAMIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original application for Rufinamide, providing a generic version of the anticonvulsant. Rufinamide is indicated as a…

• FDA approval · 2016-05-16
  FDA 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…

• FDA approval · 2015-12-14
  FDA 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 · 2015-11-04
  FDA Approved: FELBAMATE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved the original application for a generic felbamate product from ANI Pharmaceuticals, Inc.

• FDA approval · 2015-10-06
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for BANZEL (rufinamide) by Eisai Inc.

• FDA approval · 2015-06-25
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.

• FDA approval · 2015-06-25
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  FDA approved a supplemental application for BANZEL (rufinamide) from Eisai Inc.

• FDA approval · 2015-02-12
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  FDA approves a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.

• FDA approval · 2015-02-12
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.

• FDA approval · 2014-12-09
  FDA 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…

• FDA approval · 2014-12-09
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Onfi (clobazam) by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2014-01-16
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2013-11-21
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) filed by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2013-11-21
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2013-06-06
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.

• FDA approval · 2012-12-14
  FDA 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 …

• FDA approval · 2012-10-25
  FDA 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…

• FDA approval · 2011-07-06
  FDA 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…

• FDA approval · 2011-06-10
  FDA 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…

• FDA approval · 2011-06-10
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.

• FDA approval · 2011-03-03
  FDA Approved: BANZEL — Original Application (Eisai Inc.)

  The FDA approved the original application for BANZEL (rufinamide) from Eisai Inc. for the treatment of seizures associated with Lennox-Gasta…

• FDA approval · 2011-01-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited, advancing the approval status of its generic …

• FDA approval · 2010-11-08
  FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc., updating/expanding its label.