Multiple Sclerosis

• FDA approval · 2021-01-15
  FDA Approved: BACLOFEN — Original Application (MAlA Pharmaceuticals, Inc.)

  FDA approved the original application for baclofen, authorizing its marketing as a generic drug from MAlA Pharmaceuticals, Inc.

• FDA approval · 2020-12-30
  FDA Approved: FINGOLIMOD — Original Application (Ascend Laboratories, LLC)

  The FDA approved the original application for a generic fingolimod hydrochloride product from Ascend Laboratories, LLC, enabling a generic v…

• FDA approval · 2020-12-18
  FDA Approved: FINGOLIMOD — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for fingolimod (generic), enabling a generic version of the MS therapy.

• FDA approval · 2020-12-15
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (MSN LABORATORIES PRIVATE LIMITED)

  FDA approved a supplemental application for teriflunomide filed by MSN Laboratories Private Limited.

• FDA approval · 2020-12-14
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Ocrevus (ocrelizumab) from Genentech, Inc. This action approves changes to the BLA submission fo…

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• FDA approval · 2020-11-20
  FDA Tentative Approval: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA issued tentative approval for Bayer's supplemental application for BETASERON (interferon beta-1b), indicating the product meets regu…

• FDA approval · 2020-11-09
  FDA Approved: GLATOPA — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for GLATOPA (glatiramer acetate) submitted by Sandoz Inc.

• FDA approval · 2020-11-09
  FDA Approved: GLATOPA — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for GLATOPA (glatiramer acetate) from Sandoz Inc., making it an approved generic treatment for relap…

• FDA approval · 2020-11-06
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

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

• FDA approval · 2020-11-06
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Ocrevus (ocrelizumab) from Genentech, Inc.

• FDA approval · 2020-11-03
  FDA Approved: BACLOFEN — Supplemental Application (Northstar RxLLC)

  The FDA approved a supplemental application for baclofen from Northstar RxLLC, finalizing changes to an approved generic product.

• FDA approval · 2020-10-28
  FDA Approved: FINGOLIMOD HYDROCHLORIDE — Original Application (Accord Healthcare Inc.)

  FDA approved fingolimod hydrochloride as an Original Application generic product (ANDA 207991) from Accord Healthcare Inc. for the treatment…

• FDA approval · 2020-10-22
  FDA Approved: TIZANIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for tizanidine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2020-10-14
  FDA Approved: FINGOLIMOD — Original Application (Zydus Lifesciences Limited)

  The FDA approved Fingolimod from Zydus Lifesciences Limited as an Original Application for the treatment of relapsing forms of multiple scle…

• FDA approval · 2020-10-14
  FDA Approved: DIMETHYL FUMARATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' original ANDA for dimethyl fumarate, a generic version of the MS therapy Tecfidera, for relapsing fo…

• FDA approval · 2020-10-09
  FDA Approved: BACLOFEN — Original Application (Method Pharmaceuticals LLC)

  FDA approved an original application for baclofen from Method Pharmaceuticals LLC, making a generic version available.

• FDA approval · 2020-10-06
  FDA Approved: DIMETHYL FUMARATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic dimethyl fumarate in an original application for the treatment of relapsing forms of multiple sclerosis.

• FDA approval · 2020-09-24
  FDA Approved: DIMETHYL FUMARATE — Original Application (MSN LABORATORIES PRIVATE LIMITED)

  FDA has approved the Original Application for Dimethyl Fumarate by MSN Laboratories Private Limited.

• FDA approval · 2020-09-24
  FDA Approved: DIMETHYL FUMARATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's original ANDA for dimethyl fumarate, authorizing a generic version of the drug.

• FDA approval · 2020-09-24
  FDA Approved: DIMETHYL FUMARATE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for dimethyl fumarate (generic) for the treatment of relapsing forms of multiple scle…

• FDA approval · 2020-09-24
  FDA Approved: DIMETHYL FUMARATE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC’s generic dimethyl fumarate through an original ANDA submission.

• FDA approval · 2020-09-24
  FDA Approved: DIMETHYL FUMARATE — Original Application (Zydus Lifesciences Limited)

  The FDA approved Zydus Lifesciences Limited's original application for dimethyl fumarate, enabling a generic version of the MS treatment to …

• FDA approval · 2020-09-10
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s supplemental application for dalfampridine.

• FDA approval · 2020-08-21
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for VUMERITY (diroximel fumarate).

• FDA approval · 2020-08-14
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for dalfampridine from Micro Labs Limited.