Multiple Sclerosis

• FDA approval · 2016-02-29
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Tecfidera (dimethyl fumarate).

• FDA approval · 2015-12-22
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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

• FDA approval · 2015-12-22
  FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for the PLEGRIDY PEN auto-injector to administer peginterferon beta-1a (Plegridy) for multiple s…

• FDA approval · 2015-12-22
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for Avonex (interferon beta-1a), indicating a modification to the product's labeling or indic…

• FDA approval · 2015-12-22
  FDA Approved: REBIF — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for REBIF (interferon beta-1a) from EMD Serono, Inc.

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• FDA approval · 2015-12-03
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

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

• FDA approval · 2015-10-16
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  FDA approves Biogen's supplemental application for Tecfidera (dimethyl fumarate). The action updates the drug's labeling to reflect the supp…

• FDA approval · 2015-10-02
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

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

• FDA approval · 2015-09-28
  FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for tizanidine submitted by Apotex Corp.

• FDA approval · 2015-09-25
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for BETASERON (interferon beta-1b) to update the product labeling.

• FDA approval · 2015-08-04
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2015-08-03
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for COPAXONE (glatiramer acetate) from Teva Neuroscience, Inc., resulting in an updated label/indica…

• FDA approval · 2015-07-14
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Tecfidera (dimethyl fumarate). This represents an approved update to the product's la…

• FDA approval · 2015-07-02
  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 · 2015-06-16
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for TECFIDERA (dimethyl fumarate), updating/authorizing changes to its labeling.

• FDA approval · 2015-06-01
  FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for mitoxantrone hydrochloride, submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2015-05-01
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GILENYA (fingolimod HCl) from Novartis Pharmaceuticals Corporation. The action indicates an …

• FDA approval · 2015-04-16
  FDA Approved: GLATOPA — Original Application (Sandoz Inc)

  The FDA approved GLATOPA (glatiramer acetate) from Sandoz as an Original Application ANDA, a generic version of Copaxone for multiple sclero…

• FDA approval · 2015-03-06
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for Tecfidera (dimethyl fumarate) from Biogen Inc. The approval updates the product labeling.

• FDA approval · 2015-02-11
  FDA Approved: GABLOFEN — Supplemental Application (Piramal Critical Care Inc)

  FDA approved a supplemental application for GABLOFEN (baclofen injection) submitted by Piramal Critical Care Inc.

• FDA approval · 2015-01-26
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

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

• FDA approval · 2014-12-14
  FDA Approved: TIZANIDINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a generic tizanidine product from Sun Pharmaceutical Industries under an ANDA. Tizanidine is…

• FDA approval · 2014-11-14
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for TECFIDERA (dimethyl fumarate) filed by Biogen.

• FDA approval · 2014-10-17
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for AUBAGIO (teriflunomide) submitted by Genzyme Corporation.

• FDA approval · 2014-09-30
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

  FDA approved a supplemental application for AMPYRA (dalfampridine) from Merz Pharmaceuticals, LLC.