Epilepsy

• FDA approval · 2012-05-18
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for Lamotrigine from Alembic Pharmaceuticals Limited, granting approval of a generic lamotrigine pro…

• FDA approval · 2012-05-03
  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.

• FDA approval · 2012-05-01
  FDA Approved: GABAPENTIN — Original Application (Acella Pharmaceuticals, LLC)

  FDA approves Acella Pharmaceuticals' Gabapentin generic (ANDA 076403). The approval allows the generic product to be marketed for the same i…

• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA granted supplemental approval for a generic levetiracetam product from Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Levetiracetam by Dr. Reddy's Laboratories Limited under the ANDA, reflecting an approved additio…

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• FDA approval · 2012-04-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for levetiracetam by Aurobindo Pharma Limited, approving this generic product under the ANDA.

• FDA approval · 2012-04-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for levetiracetam from BluePoint Laboratories under an ANDA. This indicates a formal approval of the…

• FDA approval · 2012-04-25
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lamotrigine by Aurobindo Pharma Limited. This action approves changes to the generic lamotri…

• FDA approval · 2012-04-11
  FDA Approved: GABAPENTIN — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for gabapentin submitted by Exelan Pharmaceuticals, Inc. This action confirms an approved supple…

• FDA approval · 2012-04-11
  FDA Approved: GABAPENTIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for gabapentin submitted by Zydus Pharmaceuticals USA Inc. under ANDA 078926.

• FDA approval · 2012-04-11
  FDA Approved: LEVETIRACETAM — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approved the original application for levetiracetam by Quagen Pharmaceuticals LLC, making a generic version of the antiepileptic availab…

• FDA approval · 2012-04-06
  FDA Approved: LEVETIRACETAM — Original Application (Hospira, Inc.)

  FDA approved Hospira, Inc.'s original ANDA for levetiracetam, establishing a generic version of the anti-seizure medication Keppra. Levetira…

• FDA approval · 2012-03-27
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for a Lamotrigine product from Unichem Pharmaceuticals (USA), Inc., effectively approving a gene…

• FDA approval · 2012-03-26
  FDA Approved: LAMOTRIGINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for lamotrigine from Glenmark Pharmaceuticals (ANDA 079099).

• FDA approval · 2012-03-23
  FDA Approved: GABAPENTIN — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' original Abbreviated New Drug Application for gabapentin, authorizing a generic gabapentin product.

• FDA approval · 2012-03-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for lamotrigine from Dr. Reddy's Laboratories Limited. The approval concerns the generic lamotri…

• FDA approval · 2012-03-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for Lamotrigine from Alembic Pharmaceuticals Limited, sanctioning an updated approval for the ge…

• FDA approval · 2012-03-15
  FDA Approved: DIVALPROEX SODIUM — Original Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved Dr. Reddy's Laboratories' original application for divalproex sodium, a generic anticonvulsant, for use in conditions such …

• FDA approval · 2012-03-14
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Lamotrigine from Sun Pharmaceutical Industries, Inc. The action indicates a labeling update or p…

• FDA approval · 2012-02-27
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2012-02-01
  FDA Approved: PRIMIDONE — Supplemental Application (Lannett Company, Inc.)

  FDA approves Lannett's supplemental ANDA for Primidone (PRIMIDONE), granting approval of a generic version.

• FDA approval · 2012-01-31
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit from OWP Pharmaceuticals, expanding the lamotrigine product offering. The approv…

• FDA approval · 2012-01-27
  FDA Approved: EQUETRO — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for EQUETRO (carbamazepine) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2012-01-26
  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 · 2012-01-26
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for the generic anticonvulsant carbamazepine from Chartwell RX, LLC.