Multiple Sclerosis

• EMA approval · 2017-11-10
  New medicine for multiple sclerosis

  EMA announces a new medicine for multiple sclerosis, indicating a new treatment option entering the European market.

• FDA approval · 2017-11-02
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for OCREVUS (ocrelizumab) from Genentech, Inc., authorizing changes to the product's labeling.

• FDA approval · 2017-10-03
  FDA Approved: GLATIRAMER ACETATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for glatiramer acetate (ANDA 206936) from Mylan Pharmaceuticals, a generic version of Copaxone for mul…

• FDA approval · 2017-10-03
  FDA Approved: GLATIRAMER ACETATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's original application (ANDA) for glatiramer acetate, a generic version of Copaxone, for the treatment of multiple sclero…

• FDA approval · 2017-09-29
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

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

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• FDA approval · 2017-08-16
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), resulting in changes to the drug's labeling.

• FDA approval · 2017-05-26
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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

• FDA approval · 2017-03-28
  FDA Approved: OCREVUS — Original Application (Genentech, Inc.)

  FDA approved Ocrevus (ocrelizumab) in an original application from Genentech for the treatment of multiple sclerosis.

• FDA approval · 2017-03-03
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a generic Tizanidine Hydrochloride from Zydus Lifesciences Limited.

• FDA approval · 2017-01-23
  FDA Approved: DALFAMPRIDINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for dalfampridine as a generic product manufactured by Aurobindo Pharma Limited.

• FDA approval · 2017-01-23
  FDA Approved: DALFAMPRIDINE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s original application for dalfampridine (generic). This marks the approval of a generic dalfampridine pro…

• FDA approval · 2017-01-19
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approves Biogen's supplemental application for TECFIDERA (dimethyl fumarate), indicating an additional regulatory action related to …

• FDA approval · 2016-12-22
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

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

• FDA approval · 2016-11-29
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GILENYA (fingolimod HCl) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2016-11-29
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for AUBAGIO (teriflunomide) filed by Genzyme Corporation. The action updates the product's label…

• FDA approval · 2016-11-18
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for COPAXONE (glatiramer acetate) by Teva Neuroscience, Inc. The decision signals an approved mo…

• FDA approval · 2016-11-15
  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 · 2016-10-13
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

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

• FDA approval · 2016-09-30
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for LIORESAL (baclofen) from Amneal Pharmaceuticals LLC, signaling a change to the existing NDA.

• FDA approval · 2016-09-27
  FDA Approved: REBIF — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for Rebif (interferon beta-1a) submitted by EMD Serono, Inc. This action updates the labeling to ref…

• FDA approval · 2016-08-30
  FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Kesimpta (ofatumumab) submitted by Novartis Pharmaceuticals Corporation, expanding the regul…

• FDA approval · 2016-07-14
  FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Plegridy Pen, a pen-style autoinjector for peginterferon beta-1a, expanding its deliv…

• FDA approval · 2016-06-02
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

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

• FDA approval · 2016-04-19
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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

• FDA approval · 2016-03-14
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

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