Epilepsy

• FDA approval · 2009-11-18
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine by Torrent Pharmaceuticals Limited to update labeling.

• FDA approval · 2009-11-18
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Vimpat (lacosamide) to expand its approved indications.

• FDA approval · 2009-11-18
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc. This action signifies an additional regulatory clearance rela…

• FDA approval · 2009-11-16
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Levetiracetam, expanding the product's approved formulation/indication.

• FDA approval · 2009-11-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for a generic formulation of levetiracetam by Torrent Pharmaceuticals Limited.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2009-11-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for LEVETIRACETAM from Lupin Pharmaceuticals, marking approval of a generic levetiracetam product.

• FDA approval · 2009-11-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approves a supplemental application for levetiracetam from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2009-11-04
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc. The document does not specify the cha…

• FDA approval · 2009-11-04
  FDA Approved: LAMOTRIGINE — Original Application (Aurobindo Pharma Limited)

  FDA approved a new generic lamotrigine product from Aurobindo Pharma Limited under an Original Application (ANDA).

• FDA approval · 2009-11-02
  FDA Approved: LEVETIRACETAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for levetiracetam submitted by Mylan Pharmaceuticals Inc. (ANDA 076919).

• FDA approval · 2009-10-27
  FDA Approved: LEVETIRACETAM — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals' generic levetiracetam via an original application, enabling a generic version of the anti-seizure m…

• FDA approval · 2009-10-15
  FDA Approved: CLONAZEPAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a clonazepam generic product from Aurobindo Pharma Limited.

• FDA approval · 2009-10-14
  FDA Approved: TOPIRAMATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for Topiramate Sprinkle from Heritage Pharmaceuticals (d/b/a Avet), a generic version of topiramate. It is ind…

• FDA approval · 2009-10-14
  FDA Approved: TOPIRAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for Topiramate from Zydus Lifesciences Limited, indicating regulatory approval of a generic Topiramate…

• FDA approval · 2009-09-30
  FDA Approved: TOPIRAMATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Topiramate from Cipla USA Inc., reflecting an approved supplemental change to a previously autho…

• FDA approval · 2009-09-22
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2009-09-21
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approves a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc. under ANDA078947, confirming the continued av…

• FDA approval · 2009-09-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for lamotrigine filed by Dr. Reddy's Laboratories Limited.

• FDA approval · 2009-09-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Lamotrigine by Dr. Reddy's Laboratories Limited, updating an existing Lamotrigine product. T…

• FDA approval · 2009-09-15
  FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)

  The FDA approved a supplemental application for the generic anticonvulsant levetiracetam from Patrin Pharma, Inc. (ANDA078582).

• FDA approval · 2009-08-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for LEVETIRACETAM by Sun Pharmaceutical Industries, Inc., updating labeling based on the submission.…

• FDA approval · 2009-08-20
  FDA Approved: LEVETIRACETAM SOLUTION — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application to add a levetiracetam solution dosage form (generic) under Chartwell RX, LLC.

• FDA approval · 2009-08-04
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA has approved a supplemental application for divalproex sodium from BluePoint Laboratories.

• FDA approval · 2009-07-31
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2009-07-30
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

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