Epilepsy

• FDA approval · 2012-10-25
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer Inc, indicating approval of changes to th…

• 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 · 2012-10-22
  FDA Approved: FYCOMPA — Original Application (Eisai Inc.)

  FDA approved FYCOMPA (perampanel) through Eisai's original NDA for treatment of seizures associated with epilepsy, beginning with partial-on…

• FDA approval · 2012-10-19
  FDA Approved: OXTELLAR XR — Original Application (Supernus Pharmaceuticals, Inc.)

  FDA approves OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals as an original application for an extended-release formulation to tre…

• FDA approval · 2012-10-19
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Ethosuximide from Bionpharma Inc., confirming its use in treating absence seizures associate…

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• FDA approval · 2012-09-25
  FDA Approved: ETHOSUXIMIDE — Original Application (Chartwell RX, LLC)

  FDA approved Ethosuximide as an original generic (ANDA) for Chartwell RX, LLC.

• FDA approval · 2012-09-17
  FDA Approved: OXCARBAZEPINE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's Original Application for generic oxcarbazepine (ANDA 202961).

• FDA approval · 2012-08-01
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline LLC. This action may involve labeling or indication …

• FDA approval · 2012-08-01
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) by GlaxoSmithKline LLC, updating the labeling for the oral disintegra…

• FDA approval · 2012-08-01
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2012-07-20
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approves a supplemental application for Levetiracetam from Lupin Pharmaceuticals, indicating an approved update to labeling or indic…

• FDA approval · 2012-07-19
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to add a liquid levetiracetam formulation (LEVETIRACETAM SOLUTION) from Chartwell RX, LLC. The appro…

• FDA approval · 2012-07-19
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2012-07-19
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a generic Levetiracetam product. This notice indicates a supplemental a…

• FDA approval · 2012-06-25
  FDA Approved: PRIMIDONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Primidone submitted by Oxford Pharmaceuticals, LLC.

• FDA approval · 2012-06-19
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for carbamazepine from Torrent Pharmaceuticals Limited. This represents a supplemental approval …

• FDA approval · 2012-06-19
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited.

• FDA approval · 2012-06-07
  FDA Approved: ZONISAMIDE — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for zonisamide from Exelan Pharmaceuticals, Inc. The document indicates an approval of a supplementa…

• FDA approval · 2012-05-31
  FDA Approved: LAMOTRIGINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for lamotrigine from Glenmark Pharmaceuticals Inc., authorizing changes to the approved product.

• FDA approval · 2012-05-30
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  The FDA approved a supplemental application for zonisamide submitted by Viona Pharmaceuticals Inc under an ANDA. The action updates the labe…

• FDA approval · 2012-05-30
  FDA Approved: ZONISAMIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for zonisamide submitted by BluePoint Laboratories under ANDA 077651.

• FDA approval · 2012-05-30
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited.

• FDA approval · 2012-05-29
  FDA Approved: LEVETIRACETAM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved a generic levetiracetam under an original ANDA from Torrent Pharmaceuticals Limited. The product is indicated for seizure disor…

• FDA approval · 2012-05-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for lamotrigine filed by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2012-05-20
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Gabapentin from Ascend Laboratories, LLC, under an ANDA, indicating approval related to this gen…