Epilepsy

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic Topiramate product (Original Application) from Zydus Lifesciences Limited.

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Cipla USA Inc.)

  FDA approval of a generic Topiramate product from Cipla USA Inc. (Original Application).

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for a generic Topiramate product, expanding access to this anti-…

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's Original Application for Topiramate, enabling the generic Topiramate to be marketed.

• FDA approval · 2009-02-27
  FDA Approved: DIVALPROEX SODIUM — Original Application (BluePoint Laboratories)

  FDA approved the original application for divalproex sodium (generic) by BluePoint Laboratories.

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• FDA approval · 2009-02-19
  FDA Approved: LAMOTRIGINE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved an original application for a generic lamotrigine product manufactured by Glenmark Pharmaceuticals Inc., expanding generic …

• FDA approval · 2009-02-12
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA XR (levetiracetam) from UCB, Inc.

• FDA approval · 2009-02-10
  FDA Approved: LEVETIRACETAM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original application for levetiracetam, enabling a generic version of the antiseizure medication…

• FDA approval · 2009-01-29
  FDA Approved: MYSOLINE — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for MYSOLINE (primidone) submitted by Bausch Health US, LLC.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's Original Application for lamotrigine, enabling a generic lamotrigine product.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE KIT — Original Application (OWP Pharmaceuticals, Inc.)

  FDA approves Lamotrigine Kit under an original ANDA application by OWP Pharmaceuticals, Inc. for generic lamotrigine products.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals Inc.'s original ANDA for lamotrigine, establishing a generic lamotrigine product.

• FDA approval · 2009-01-27
  FDA Approved: DIVALPROEX SODIUM — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved an original application for a generic divalproex sodium product from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Aurobindo Pharma Limited)

  The FDA approved an original ANDA for Lamotrigine from Aurobindo Pharma Limited, providing a generic lamotrigine product. The product is ind…

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' generic lamotrigine under Original Application (ANDA). The approval covers the generic product for la…

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for lamotrigine from Zydus Pharmaceuticals USA Inc., establishing a generic version of the anti-epileptic and…

• FDA approval · 2009-01-27
  FDA Approved: LAMOTRIGINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original ANDA for lamotrigine, enabling a generic lamotrigine product to reach the market.

• FDA approval · 2009-01-23
  FDA Approved: DIVALPROEX SODIUM — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's original application for divalproex sodium (generic).

• FDA approval · 2009-01-22
  FDA Approved: LAMOTRIGINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for lamotrigine, a generic version manufactured by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2009-01-22
  FDA Approved: LAMOTRIGINE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approved the Original Application for Lamotrigine as a generic product from Dr. Reddy's Laboratories Limited.

• FDA approval · 2009-01-16
  FDA Approved: LEVETIRACETAM — Original Application (Bionpharma Inc.)

  FDA approved a generic levetiracetam product from Bionpharma Inc. under an Original Application (ANDA 079120), expanding access to this anti…

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for a generic levetiracetam product.

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis's original application for levetiracetam, a generic version of the antiseizure medication used to treat epilepsy. The a…

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (BluePoint Laboratories)

  FDA approved the original application for levetiracetam as a generic product from BluePoint Laboratories.

• FDA approval · 2009-01-15
  FDA Approved: LEVETIRACETAM — Original Application (SOHM, Inc.)

  FDA approved an original ANDA for levetiracetam from SOHM, Inc., making a generic version of the anticonvulsant available.