Multiple Sclerosis

• FDA approval · 2019-03-11
  FDA Approved: DALFAMPRIDINE — Original Application (Micro Labs Limited)

  FDA approved dalfampridine under an Original Application for Micro Labs Limited. The drug is intended to improve walking in adults with mult…

• FDA approval · 2019-01-25
  FDA Approved: TIZANIDINE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA for tizanidine, establishing a generic version of the muscle relaxant.

• FDA approval · 2019-01-16
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

  FDA overview of a supplemental application for CAMPATH (alemtuzumab) submitted by Genzyme Corporation.

• FDA approval · 2019-01-11
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2019-01-07
  FDA Approved: TERIFLUNOMIDE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's generic teriflunomide through an Original Application (ANDA).

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• FDA approval · 2018-11-30
  FDA Approved: TERIFLUNOMIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  The FDA has approved a generic version of teriflunomide for relapsing forms of multiple sclerosis, filed by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2018-11-23
  FDA Approved: BACLOFEN — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the Original Application for Baclofen from Zydus Pharmaceuticals (USA) Inc., establishing a generic baclofen product. Baclofen …

• FDA approval · 2018-11-15
  FDA Approved: TERIFLUNOMIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's generic teriflunomide under an Original Application (ANDA 209663), enabling market entry for a generic version o…

• FDA approval · 2018-11-12
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Ocrevus (ocrelizumab) submitted by Genentech, Inc.

• FDA approval · 2018-10-26
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2018-10-26
  FDA Approved: TERIFLUNOMIDE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic teriflunomide product. This approval makes a generic version …

• FDA approval · 2018-09-07
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for Copaxone (glatiramer acetate) from Teva Neuroscience, Inc., indicating an update to the prod…

• FDA approval · 2018-09-04
  FDA Approved: TERIFLUNOMIDE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original application for a generic teriflunomide, expanding access to this disease-modifying therapy for multiple sclero…

• FDA approval · 2018-08-31
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved Bayer's supplemental application for Betaseron (interferon beta-1b), updating the product labeling.

• FDA approval · 2018-07-30
  FDA Approved: DALFAMPRIDINE — Original Application (Ascend Laboratories, LLC)

  FDA approval for the original ANDA of dalfampridine from Ascend Laboratories, LLC.

• FDA approval · 2018-07-11
  FDA Approved: DALFAMPRIDINE — Original Application (Accord Healthcare Inc.)

  FDA approved the original application for dalfampridine as a generic (Accord Healthcare Inc.), marking the approval of a generic dalfampridi…

• FDA approval · 2018-06-08
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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

• FDA approval · 2018-05-11
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2018-04-18
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for TYSABRI (natalizumab).

• FDA approval · 2018-02-12
  FDA Approved: GLATOPA — Original Application (Sandoz Inc)

  The FDA approved GLATOPA as an Original Application for glatiramer acetate by Sandoz Inc, a generic version of Copaxone. It is indicated for…

• FDA approval · 2018-01-23
  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 · 2017-12-19
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

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

• FDA approval · 2017-12-15
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2017-12-15
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

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

• FDA approval · 2017-11-28
  FDA Approved: BACLOFEN — Original Application (TruPharma LLC)

  FDA approved the original ANDA for baclofen, a generic version produced by TruPharma LLC.