Epilepsy

• FDA approval · 2013-08-06
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DILANTIN (extended phenytoin sodium) submitted by Viatris Specialty LLC.

• FDA approval · 2013-08-05
  FDA Approved: CERETEC — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approves a supplemental application for CERETEC (TECHNETIUM TC-99M EXAMETAZIME) from Medi-Physics Inc. dba GE Healthcare.

• FDA approval · 2013-07-31
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) from AbbVie Inc. This action represents an approved supplement t…

• FDA approval · 2013-07-29
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) by Novartis Pharmaceuticals Corporation, typically resulting in upda…

• FDA approval · 2013-07-26
  FDA Approved: CLONAZEPAM — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for clonazepam filed by Par Health USA, LLC.

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• FDA approval · 2013-07-25
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc., authorizing changes to the drug's labeling.

• FDA approval · 2013-07-25
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc.

• FDA approval · 2013-07-25
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam) submitted by UCB, Inc.

• FDA approval · 2013-07-15
  FDA Approved: LAMOTRIGINE — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's original ANDA for lamotrigine, a generic version of the anticonvulsant. The approv…

• FDA approval · 2013-07-12
  FDA Approved: GABAPENTIN — Original Application (ACI Healthcare USA, Inc.)

  FDA approved a generic gabapentin product under an Original Application filed by ACI Healthcare USA, Inc.

• FDA approval · 2013-07-09
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for EPITOL (carbamazepine) filed by Teva Pharmaceuticals USA, Inc., under ANDA070541.

• FDA approval · 2013-06-30
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved Eisai's supplemental application for FYCOMPA (perampanel), resulting in changes to the product labeling.

• FDA approval · 2013-06-26
  FDA Approved: LEVETIRACETAM — Original Application (Sagent Pharmaceuticals)

  FDA approves the original application for a generic levetiracetam product from Sagent Pharmaceuticals.

• FDA approval · 2013-06-19
  FDA Approved: LAMOTRIGINE — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's generic Lamotrigine under an Original Application (ANDA) for use in treating epilepsy and bipolar disorder.

• FDA approval · 2013-06-14
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for DEPAKOTE ER (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2013-06-14
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, indicating regulatory approval to…

• FDA approval · 2013-06-14
  FDA Approved: LAMOTRIGINE — Original Application (Ascend Laboratories, LLC)

  FDA approves Ascend Laboratories, LLC's original ANDA for lamotrigine, enabling the marketing of a lamotrigine generic product.

• FDA approval · 2013-06-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine from Sun Pharmaceutical Industries, Inc., indicating an update to the product's re…

• FDA approval · 2013-06-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2013-05-31
  FDA Approved: CLONAZEPAM — Supplemental Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's supplemental application for clonazepam (generic) under ANDA075468, authorizing an additional clonazepam p…

• FDA approval · 2013-04-26
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for Oxcarbazepine by Advagen Pharma Limited under ANDA 077747.

• FDA approval · 2013-04-09
  FDA Approved: GABAPENTIN — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for gabapentin submitted by Advagen Pharma Ltd.

• FDA approval · 2013-03-06
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2013-03-06
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC. This action adds the 125 mg strength to the…

• FDA approval · 2013-02-28
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for levetiracetam from BluePoint Laboratories under ANDA 078993. This approval relates to the generi…