Epilepsy

• FDA approval · 2010-11-04
  FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for lamotrigine from Jubilant Cadista Pharmaceuticals Inc., indicating approved changes to labeling.

• FDA approval · 2010-10-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for zonisamide submitted by Sun Pharmaceutical Industries, Inc., indicating an approved update t…

• FDA approval · 2010-10-25
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application to add an oral solution form of levetiracetam (LEVETIRACETAM SOLUTION) manufactured by Chartwell…

• FDA approval · 2010-10-24
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2010-10-24
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for EQUETRO (carbamazepine) from Validus Pharmaceuticals LLC.

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• FDA approval · 2010-10-22
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for oxcarbazepine submitted by Advagen Pharma Limited.

• FDA approval · 2010-10-11
  FDA Approved: CELONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for CELONTIN (methsuximide) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2010-10-08
  FDA Approved: LEVETIRACETAM — Original Application (NorthStar RxLLC)

  FDA approved a generic version of levetiracetam under an Original Application for NorthStar RxLLC.

• FDA approval · 2010-09-29
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited. It indicates regulatory approval for chang…

• FDA approval · 2010-09-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for levetiracetam under an ANDA filed by Dr. Reddy's Laboratories Limited.

• FDA approval · 2010-09-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental abbreviated new drug application for Levetiracetam from Dr. Reddy's Laboratories Limited.

• FDA approval · 2010-09-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)

  FDA approved a supplemental application for levetiracetam from Patrin Pharma, Inc., issuing approval for their generic product under ANDA078…

• FDA approval · 2010-09-14
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) submitted by Parke-Davis Div of Pfizer Inc. The approval relates to …

• FDA approval · 2010-08-13
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited, indicating an update to the generic's labeling post-…

• FDA approval · 2010-08-11
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  The FDA approved a supplemental application for zonisamide from Viona Pharmaceuticals Inc.

• FDA approval · 2010-07-28
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, Inc., indicating regulatory action on the lamotrigine …

• FDA approval · 2010-07-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Glenmark's generic lamotrigine product. The approval confirms the generic's labeling and regulat…

• FDA approval · 2010-07-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited.

• FDA approval · 2010-07-28
  FDA Approved: LEVETIRACETAM — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's original application for levetiracetam (generic).

• FDA approval · 2010-06-29
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for oxcarbazepine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2010-06-29
  FDA Approved: OXCARBAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for oxcarbazepine by ANI Pharmaceuticals, Inc., updating regulatory approvals for this product.

• FDA approval · 2010-06-27
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam submitted by Teva Pharmaceuticals USA, Inc., marking an updated regulatory action for…

• FDA approval · 2010-06-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for LEVETIRACETAM from Torrent Pharmaceuticals Limited, enabling a generic version of the anti-seizu…

• FDA approval · 2010-06-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc., granting approval for changes to the alread…

• FDA approval · 2010-06-15
  FDA Approved: LORAZEPAM — Original Application (Pharmaceutical Associates, Inc.)

  FDA approved Lorazepam under an Original Application for an ANDA held by Pharmaceutical Associates, Inc., establishing a generic version of …