Multiple Sclerosis

• FDA approval · 2024-06-10
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  FDA approved Genzyme Corporation's supplemental application for AUBAGIO (teriflunomide).

• FDA approval · 2024-06-05
  FDA Approved: PONVORY — Supplemental Application (Janssen Pharmaceuticals, Inc)

  The FDA approved Janssen's supplemental application for PONVORY (ponesimod), expanding its labeling. The indication relates to treatment of …

• FDA approval · 2024-06-05
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Mayzent (siponimod) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2024-06-05
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2024-05-30
  FDA Approved: FINGOLIMOD HYDROCHLORIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for fingolimod hydrochloride from Accord Healthcare Inc., enabling the generic version of the multip…

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• FDA approval · 2024-05-30
  FDA Approved: FINGOLIMOD — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for fingolimod hydrochloride (Fingolimod) submitted by Ascend Laboratories, LLC under ANDA208004.

• FDA approval · 2024-05-29
  FDA Approved: FINGOLIMOD — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for fingolimod from XLCare Pharmaceuticals Inc., indicating regulatory approval of a supplemental su…

• FDA approval · 2024-05-14
  FDA Approved: FINGOLIMOD — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved the supplemental application for fingolimod hydrochloride, enabling a generic version of the multiple sclerosis drug fingolimod…

• FDA approval · 2024-05-10
  FDA Approved: MAVENCLAD — Supplemental Application (EMD Serono, Inc.)

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

• FDA approval · 2024-04-18
  FDA Approved: BACLOFEN — Supplemental Application (Wilshire Pharmaceuticals, Inc.)

  FDA approves a supplemental application for baclofen from Wilshire Pharmaceuticals, Inc., updating the existing baclofen product.

• FDA approval · 2024-04-16
  FDA Approved: FINGOLIMOD — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for fingolimod submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2024-04-15
  FDA Approved: FINGOLIMOD — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA approved a supplemental application for fingolimod submitted by Dr. Reddy's Laboratories. This action approves changes associated with t…

• FDA approval · 2024-03-22
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

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

• FDA approval · 2024-03-19
  FDA Approved: GLATOPA — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for GLATOPA (glatiramer acetate) from Sandoz Inc, updating regulatory status for this product.

• FDA approval · 2024-03-19
  FDA Approved: GLATOPA — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2024-03-12
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The U.S. FDA has approved Biogen's supplemental application for Tecfidera (dimethyl fumarate) related to its use in multiple sclerosis, refl…

• FDA approval · 2024-02-28
  FDA Approved: FINGOLIMOD — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic fingolimod product from Aurobindo Pharma Limited (ANDA 207983) under Original Application. Fingolimod is used to trea…

• FDA approval · 2024-02-15
  FDA Approved: GLATIRAMER ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for glatiramer acetate by Mylan Pharmaceuticals, authorizing a generic version of the therapy for mu…

• FDA approval · 2024-02-15
  FDA Approved: GLATIRAMER ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for glatiramer acetate from Mylan Pharmaceuticals, indicating a regulatory change to this produc…

• FDA approval · 2024-02-08
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' supplemental application for a generic dimethyl fumarate product. The approval enables the generic t…

• FDA approval · 2024-02-08
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for dimethyl fumarate (ANDA 210305) by Cipla USA Inc., enabling the continued market availability of…

• FDA approval · 2024-02-07
  FDA Approved: MAVENCLAD — Supplemental Application (EMD Serono, Inc.)

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

• FDA approval · 2024-02-05
  FDA Approved: BACLOFEN — Supplemental Application (TruPharma LLC)

  FDA approved TruPharma LLC's supplemental application for baclofen (generic) under the approved regulatory pathway.

• FDA approval · 2024-01-19
  FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Kesimpta (ofatumumab) submitted by Novartis Pharmaceuticals Corporation. This action updates the…

• FDA approval · 2024-01-19
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for OCREVUS (ocrelizumab) by Genentech, Inc., expanding the approved use for multiple sclerosis.