Epilepsy

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

  FDA supplemental approval for Topiramate by Aurobindo Pharma Limited.

• FDA approval · 2010-02-17
  FDA Approved: VALPROATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for valproate sodium, a generic anticonvulsant.

• FDA approval · 2010-01-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a Supplemental Application for carbamazepine by Sun Pharmaceutical Industries, Inc. under an ANDA, marking an approved change t…

• FDA approval · 2010-01-27
  FDA Approved: TOPIRAMATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Cipla USA Inc. to market a generic topiramate product.

• FDA approval · 2010-01-21
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

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• FDA approval · 2010-01-21
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lamotrigine Kit submitted by OWP Pharmaceuticals, Inc.

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for divalproex sodium submitted by Upsher-Smith Laboratories, LLC.

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for divalproex sodium. The approval covers the submitted supplemental chang…

• FDA approval · 2010-01-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approves a supplemental application for divalproex sodium filed by Bionpharma Inc., resulting in an approved update under the ANDA proce…

• FDA approval · 2010-01-20
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Supplemental Application (NORTHSTAR RX LLC)

  The FDA approved a supplemental application for clorazepate dipotassium submitted by Northstar RX LLC.

• FDA approval · 2010-01-14
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Supplemental Application (Aurolife Pharma LLC)

  FDA approved a supplemental application for Clorazepate Dipotassium by Aurolife Pharma LLC, granting regulatory approval for this generic pr…

• FDA approval · 2010-01-12
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2010-01-07
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2010-01-06
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valproic acid submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2010-01-06
  FDA Approved: VALPROIC ACID — Supplemental Application (Xttrium Laboratories Inc.)

  FDA approved a supplemental application for valproic acid from Xttrium Laboratories Inc., granting approval of a generic product.

• FDA approval · 2010-01-04
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA has approved a supplemental application for ethosuximide submitted by PAI Holdings/PAI Pharma.

• FDA approval · 2009-12-30
  FDA Approved: GABAPENTIN — Original Application (Exelan Pharmaceuticals, Inc.)

  The FDA approves Exelan Pharmaceuticals, Inc.'s original application for gabapentin as a generic product.

• FDA approval · 2009-12-15
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for phenytoin sodium from Sun Pharmaceutical Industries, Inc., to modify/expand the drug's label…

• FDA approval · 2009-12-15
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Carbamazepine (generic) submitted by Chartwell RX, LLC.

• FDA approval · 2009-12-15
  FDA Approved: PHENYTOIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2009-12-08
  FDA Approved: LEVETIRACETAM — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' original application for a generic levetiracetam product (LEVETIRACETAM) for use in treating seizure…

• FDA approval · 2009-12-02
  FDA Approved: FOSPHENYTOIN SODIUM — Original Application (West-Ward Pharmaceuticals Corp)

  FDA approved the original application for fosphenytoin sodium (generic) from West-Ward Pharmaceuticals Corp, authorizing its use as an antic…

• FDA approval · 2009-11-25
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Carbamazepine from Apotex Corp.

• FDA approval · 2009-11-20
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) filed by Parke-Davis Div of Pfizer Inc under ANDA080258.

• FDA approval · 2009-11-20
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for gabapentin from BluePoint Laboratories, granting approval to market a generic gabapentin product…