Multiple Sclerosis

• FDA approval · 2023-04-11
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for TYSABRI (natalizumab). The action updates the product labeling to reflect the requested c…

• FDA approval · 2023-04-11
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Micro Labs Limited)

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

• FDA approval · 2023-03-16
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a teriflunomide generic product from Aurobindo Pharma Limited.

• FDA approval · 2023-03-13
  FDA Approved: TERIFLUNOMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved the original application for a generic version of teriflunomide.

• FDA approval · 2023-03-13
  FDA Approved: TERIFLUNOMIDE — Original Application (Biocon Pharma Inc.)

  FDA approved the original ANDA for teriflunomide from Biocon Pharma Inc., authorizing a generic version of the multiple sclerosis therapy.

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• FDA approval · 2023-02-22
  FDA Approved: BACLOFEN — Original Application (Nexus Pharmaceuticals LLC)

  FDA approves Nexus Pharmaceuticals LLC's original ANDA for baclofen, a generic treatment for spasticity conditions.

• FDA approval · 2023-02-10
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for VUMERITY (diroximel fumarate) by Biogen Inc.

• FDA approval · 2023-02-10
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Tecfidera (dimethyl fumarate), resulting in updated labeling for the drug.

• FDA approval · 2023-01-31
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MAYZENT (siponimod) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-01-12
  FDA Approved: BAFIERTAM — Supplemental Application (Banner Life Sciences LLC)

  The FDA approved a supplemental application for BAFIERTAM (monomethyl fumarate) submitted by Banner Life Sciences LLC.

• FDA approval · 2023-01-05
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for teriflunomide, supporting a generic version of the multiple sclerosis therapy.

• FDA approval · 2023-01-04
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

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

• FDA approval · 2022-12-09
  FDA Approved: TASCENSO ODT — Original Application (Cycle Pharmaceuticals Ltd)

  The FDA approved TASCENSO ODT, an oral disintegrating tablet containing fingolimod lauryl sulfate, under an original application by Cycle Ph…

• FDA approval · 2022-11-16
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

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

• FDA approval · 2022-11-02
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for the generic Teriflunomide from Aurobindo Pharma Limited under an ANDA. This allows the produ…

• FDA approval · 2022-11-01
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (MSN LABORATORIES PRIVATE LIMITED)

  FDA approved a supplemental application for teriflunomide submitted by MSN Laboratories Private Limited. This action expands the regulatory …

• FDA approval · 2022-10-18
  FDA Approved: DIMETHYL FUMARATE — Original Application (Solco Healthcare US, LLC)

  The FDA approved the original application for a generic Dimethyl Fumarate manufactured by Solco Healthcare US, LLC. Dimethyl Fumarate is use…

• FDA approval · 2022-10-07
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for teriflunomide, granting approval of a generic product for the treatment o…

• FDA approval · 2022-09-29
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for Tecfidera (dimethyl fumarate) submitted by Biogen Inc., resulting in updated labeling.

• FDA approval · 2022-09-29
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for VUMERITY (diroximel fumarate), indicating an approved modification to its labeling/in…

• FDA approval · 2022-09-29
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)

  FDA supplemental application approval to offer a Zeposia 7-day starter pack (ozanimod hydrochloride) for initiation of therapy.

• FDA approval · 2022-09-21
  FDA Approved: GLATOPA — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for GLATOPA, a generic glatiramer acetate product from Sandoz Inc.

• FDA approval · 2022-09-21
  FDA Approved: GLATOPA — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for GLATOPA (glatiramer acetate) from Sandoz Inc, a generic version of glatiramer acetate.

• FDA approval · 2022-09-19
  FDA Approved: MAVENCLAD — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for Mavenclad (cladribine) submitted by EMD Serono, Inc.

• FDA approval · 2022-09-07
  FDA Approved: FINGOLIMOD — Original Application (Solco Healthcare US, LLC)

  The FDA approved the original application for fingolimod from Solco Healthcare US, LLC, enabling a generic fingolimod product for multiple s…