Epilepsy

• FDA approval · 2010-05-31
  FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's supplemental application for Zonisamide (zonisamide), indicating an update to the approved product.

• FDA approval · 2010-05-28
  FDA Approved: VALPROIC ACID — Original Application (QUAGEN PHARMACEUTICALS LLC)

  The FDA approved a generic version of valproic acid from Quagen Pharmaceuticals LLC under an Original Abbreviated New Drug Application.

• FDA approval · 2010-05-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2010-05-20
  FDA Approved: PRIMIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

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

• FDA approval · 2010-05-20
  FDA Approved: PRIMIDONE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Primidone (Actavis Pharma, Inc.) under the ANDA pathway, indicating an approved modification…

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• FDA approval · 2010-05-20
  FDA Approved: PRIMIDONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Primidone by Oxford Pharmaceuticals, LLC under an ANDA for this generic antiseizure medicati…

• FDA approval · 2010-05-20
  FDA Approved: PRIMIDONE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for PRIMIDONE from Lannett Company, Inc., a generic antiseizure medication. The action is linked to …

• FDA approval · 2010-05-17
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for gabapentin filed by Amneal Pharmaceuticals LLC.

• FDA approval · 2010-05-14
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Gabapentin from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2010-05-13
  FDA Approved: GABAPENTIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for gabapentin from Actavis Pharma, Inc. under ANDA075350, typically reflecting a label change or fo…

• FDA approval · 2010-05-13
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA granted supplemental approval for gabapentin submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2010-04-29
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for oxcarbazepine (ANDA077747) from Advagen Pharma Limited.

• FDA approval · 2010-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for a generic levetiracetam product from Bionpharma Inc., allowing its marketing in the United S…

• FDA approval · 2010-04-20
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc.

• FDA approval · 2010-04-19
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for ZONEGRAN (zonisamide) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2010-04-07
  FDA Approved: LEVETIRACETAM — Supplemental Application (SOHM, Inc.)

  The FDA approved a supplemental application for levetiracetam by SOHM, Inc., adding to the existing regulatory approval for the product.

• FDA approval · 2010-03-15
  FDA Approved: VALPROIC ACID — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved the supplemental application for Valproic Acid filed by PAI Holdings dba PAI Pharma.

• FDA approval · 2010-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for zonisamide from BluePoint Laboratories, signaling approval of changes to the generic product.

• FDA approval · 2010-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited. The approval confirms the changes requeste…

• FDA approval · 2010-02-26
  FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application for zonisamide (generic) under ANDA077634. This action approves the sup…

• FDA approval · 2010-02-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for levetiracetam by Bionpharma Inc. under ANDA 079120. This approval marks the availability of a ge…

• FDA approval · 2010-02-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the Supplemental Application for lamotrigine by Aurobindo Pharma Limited, resulting in approval of a generic lamotrigine produc…

• FDA approval · 2010-02-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2010-02-23
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for lamotrigine filed by Zydus Pharmaceuticals USA Inc., authorizing changes to the approved pro…

• FDA approval · 2010-02-23
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for carbamazepine (generic).