Multiple Sclerosis

• FDA label_change · 2026-02-11
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for Aubagio (teriflunomide) filed by Genzyme Corporation, resulting in labeling updates for the drug…

• FDA label_change · 2024-08-30
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)

  FDA approved a supplemental labeling to include a Zeposia 7-day starter pack for ozanimod hydrochloride.

• FDA label_change · 2024-05-09
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a Bayer supplemental application for Betaseron (interferon beta-1b), signaling changes to the product labeling.

• FDA label_change · 2024-04-12
  FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Kesimpta (ofatumumab) from Novartis Pharmaceuticals Corporation. The approval leads to chang…

• FDA label_change · 2024-02-08
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Dimethyl Fumarate from Glenmark Pharmaceuticals Inc., USA, typically resulting in label or packa…

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• FDA label_change · 2023-08-10
  FDA Approved: TASCENSO ODT — Supplemental Application (Cycle Pharmaceuticals Ltd)

  FDA granted approval of a supplemental application for TASCENSO ODT, adding fingolimod lauryl sulfate as a new orodispersible tablet formula…

• FDA label_change · 2022-08-03
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for OCREVUS (ocrelizumab) filed by Genentech, indicating an update to the product labeling for this …

• FDA label_change · 2021-11-18
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

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

• FDA label_change · 2021-11-03
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

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

• FDA label_change · 2021-01-29
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for TECFIDERA (dimethyl fumarate) submitted by Biogen Inc., resulting in changes to the drug's label…

• FDA label_change · 2020-10-29
  FDA Approved: BACLOFEN — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for baclofen submitted by Chartwell RX, LLC.

• FDA label_change · 2020-10-01
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Betaseron (interferon beta-1b) submitted by Bayer to update the product labeling.

• FDA label_change · 2020-05-15
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Ocrevus (ocrelizumab) from Genentech, Inc., resulting in labeling changes for its multiple scler…

• FDA label_change · 2019-12-19
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

  FDA approved a supplemental application for AMPYRA (dalfampridine) submitted by Merz Pharmaceuticals, LLC. The action entails a labeling cha…

• FDA label_change · 2019-08-16
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for BETASERON (interferon beta-1b) filed by Bayer, resulting in labeling changes.

• FDA label_change · 2019-08-16
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for GILENYA (fingolimod hydrochloride) submitted by Novartis Pharmaceuticals Corporation; the approv…

• EMA label_change · 2019-07-26
  Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy

  The European Medicines Agency updates restrictions for Gilenya (fingolimod) to prohibit use during pregnancy due to potential fetal harm, re…

• FDA label_change · 2019-07-24
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

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

• FDA label_change · 2019-07-10
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

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

• FDA label_change · 2015-12-24
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for Tecfidera (dimethyl fumarate) submitted by Biogen.

• FDA label_change · 2015-05-14
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for GILENYA (fingolimod hydrochloride) from Novartis, resulting in changes to the product labeli…

• FDA label_change · 2014-12-03
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for TECFIDERA (dimethyl fumarate) from Biogen, resulting in labeling changes for the product. Th…

• FDA label_change · 2013-11-07
  FDA Approved: ZANAFLEX — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved Covis Pharma US, Inc.'s supplemental application for Zanaflex (tizanidine hydrochloride).

• FDA label_change · 2013-08-20
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Tecfidera (dimethyl fumarate), resulting in a label change for this multiple sclerosi…

• FDA label_change · 2012-07-20
  FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)

  FDA approved a supplemental application for AMPYRA (dalfampridine) submitted by Merz Pharmaceuticals, resulting in an update to the drug's l…