Multiple Sclerosis

• FDA approval · 2013-02-22
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for COPAXONE (glatiramer acetate) from Teva Neuroscience, Inc.

• FDA approval · 2013-01-22
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Ampyra (dalfampridine) by Merz Pharmaceuticals, LLC.

• FDA approval · 2013-01-08
  FDA Approved: CLADRIBINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Cladribine from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2012-12-21
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

  The FDA approved a supplemental application for AMPYRA (dalfampridine) filed by Merz Pharmaceuticals, LLC. This action updates the regulator…

• FDA approval · 2012-12-11
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Betaseron (interferon beta-1b) from Bayer HealthCare Pharmaceuticals Inc.

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• FDA approval · 2012-12-05
  FDA Approved: MITOXANTRONE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved a supplemental application for mitoxantrone from Meitheal Pharmaceuticals Inc., updating the approved generic product under…

• FDA approval · 2012-11-28
  FDA Approved: TIZANIDINE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s original abbreviated new drug application for tizanidine, a generic muscle relaxant. This…

• FDA approval · 2012-09-12
  FDA Approved: AUBAGIO — Original Application (Genzyme Corporation)

  FDA approved Aubagio (teriflunomide) from Genzyme in its original application for the treatment of relapsing forms of multiple sclerosis.

• FDA approval · 2012-05-09
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GILENYA (fingolimod HCl) submitted by Novartis Pharmaceuticals Corporation to modify the pro…

• FDA approval · 2012-03-18
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GILENYA (fingolimod HCl) submitted by Novartis Pharmaceuticals Corporation. The document indicat…

• FDA approval · 2012-03-01
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GILENYA (fingolimod HCl) submitted by Novartis Pharmaceuticals Corporation, updating the pro…

• FDA approval · 2012-02-27
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for AVONEX (interferon beta-1a). This action approves a supplemental submission to modify…

• FDA approval · 2012-02-03
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s generic tizanidine hydrochloride (Original Application) for the treatment of spasticity associated with neurolog…

• FDA approval · 2012-01-20
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen Inc.'s supplemental application for TYSABRI (natalizumab). This action updates the product's labeling per the submis…

• FDA approval · 2011-11-17
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Ampyra (dalfampridine) submitted by Merz Pharmaceuticals, LLC.

• FDA approval · 2011-11-13
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lioresal (baclofen) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2011-10-07
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), resulting in a labeling update as part of a supplemental appro…

• FDA approval · 2011-09-20
  FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Kesimpta (ofatumumab) from Novartis, resulting in changes to the product's labeling.

• FDA approval · 2011-09-16
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Tysabri (Natalizumab).

• FDA approval · 2011-07-01
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GILENYA (fingolimod hydrochloride) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2011-06-17
  FDA Approved: BACLOFEN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' supplemental application for baclofen, enabling continued availability of this generic product f…

• FDA approval · 2011-04-26
  FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for mitoxantrone hydrochloride from Fresenius Kabi USA, LLC. This approval encompasses the generic p…

• FDA approval · 2011-04-01
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for TYSABRI (Natalizumab) filed by Biogen Inc. The action represents an approved regulatory update t…

• FDA approval · 2010-11-19
  FDA Approved: GABLOFEN — Original Application (Piramal Critical Care Inc)

  The FDA approved GABLOFEN (baclofen injection) under an original application from Piramal Critical Care Inc, adding a new injectable baclofe…

• FDA approval · 2010-09-23
  FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Kesimpta (ofatumumab) submitted by Novartis Pharmaceuticals Corporation.