Epilepsy

• FDA approval · 2015-01-20
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for oxcarbazepine from Glenmark Pharmaceuticals Inc., USA (ANDA 077802).

• FDA approval · 2015-01-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited, indicating an approved action on an existing…

• FDA approval · 2015-01-20
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2015-01-20
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2015-01-20
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical, Inc.'s supplemental application for oxcarbazepine under the ANDA.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-01-16
  FDA Approved: VALPROIC ACID — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approves a supplemental application for Valproic acid from Quagen Pharmaceuticals LLC (ANDA 090517).

• FDA approval · 2015-01-07
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) filed by AbbVie Inc., resulting in a regulatory update to th…

• FDA approval · 2014-12-30
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL (lamotrigine) from GlaxoSmithKline, updating the product labeling as a result of the su…

• FDA approval · 2014-12-30
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL XR (lamotrigine) from GlaxoSmithKline LLC, updating the extended-release formulatio…

• FDA approval · 2014-12-13
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2014-12-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited, reflecting changes to labeling for this generic produ…

• FDA approval · 2014-12-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine from Alembic Pharmaceuticals Limited under an ANDA. This confirms approval of a supp…

• FDA approval · 2014-12-11
  FDA Approved: LEVETIRACETAM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2014-12-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA granted a supplemental approval for Lamotrigine from Unichem Pharmaceuticals (USA), Inc. under an ANDA supplemental application. The sni…

• FDA approval · 2014-12-10
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application to authorize a Lamotrigine Kit from OWP Pharmaceuticals, Inc., expanding the approved lamotrigine pr…

• FDA approval · 2014-12-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for lamotrigine from Jubilant Cadista Pharmaceuticals Inc. This marks an approval of a generic lamot…

• FDA approval · 2014-12-09
  FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)

  FDA approved a supplemental application for Patrin Pharma's levetiracetam, a generic anticonvulsant used to treat epilepsy.

• FDA approval · 2014-12-09
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC. The approval updates the labeling for ONFI, p…

• FDA approval · 2014-12-05
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine by Aurobindo Pharma Limited, authorizing changes to an existing lamotrigine product.

• FDA approval · 2014-12-01
  FDA Approved: TOPIRAMATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA granted approval of a supplemental application for Topiramate filed by Unichem Pharmaceuticals (USA), Inc., under an ANDA.

• FDA approval · 2014-12-01
  FDA Approved: TOPIRAMATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Topiramate from Glenmark Pharmaceuticals, authorizing an update or expansion of its labeling/app…

• FDA approval · 2014-11-20
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-11-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd.

• FDA approval · 2014-11-20
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

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

• FDA approval · 2014-11-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Topiramate submitted by Zydus Lifesciences Limited.