Multiple Sclerosis

• FDA approval · 2024-12-26
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2024-12-20
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Biocon Pharma Inc.)

  The FDA approved Biocon Pharma Inc.'s supplemental application for a generic teriflunomide product, authorizing its marketing in the United …

• FDA approval · 2024-12-19
  FDA Approved: FINGOLIMOD HYDROCHLORIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for fingolimod hydrochloride by Accord Healthcare Inc., authorizing a generic version of this multip…

• FDA approval · 2024-12-18
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (SOLA Pharmaceuticals, LLC)

  FDA approved a supplemental application for dimethyl fumarate from SOLA Pharmaceuticals, LLC, granting approval for its generic product unde…

• FDA approval · 2024-12-17
  FDA Approved: FINGOLIMOD — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's supplemental application for fingolimod (generic), authorizing a generic product under ANDA208003 fo…

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• FDA approval · 2024-12-17
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories, LLC's supplemental application for Dimethyl Fumarate (generic), enabling market entry of a generic f…

• FDA approval · 2024-12-17
  FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for Tizanidine (generic), authorizing changes to the approved ANDA product.

• FDA approval · 2024-12-17
  FDA Approved: FINGOLIMOD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Fingolimod filed by Sun Pharmaceutical Industries, Inc. as a generic version of the multiple…

• FDA approval · 2024-12-17
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for dimethyl fumarate from Aurobindo Pharma Limited. This approves a generic version of the MS t…

• FDA approval · 2024-12-12
  FDA Approved: ONTRALFY — Original Application (Rosemont Pharmaceuticals, LLC)

  FDA approved ONTRALFY (tizanidine hydrochloride) under an Original Application by Rosemont Pharmaceuticals, LLC for the management of muscle…

• FDA approval · 2024-12-06
  FDA Approved: BACLOFEN — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's Baclofen Original Application, confirming a generic Baclofen product for approved indications.

• FDA approval · 2024-11-27
  FDA Approved: TIZANIDINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for tizanidine from Unichem Pharmaceuticals (USA), Inc., approving the generic product with labeling…

• FDA approval · 2024-11-04
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approves Solco Healthcare US, LLC's supplemental application for dimethyl fumarate, indicating approval of a generic version under an AN…

• FDA approval · 2024-10-11
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for dimethyl fumarate from Ascend Laboratories, LLC, indicating regulatory clearance for a suppl…

• FDA approval · 2024-10-08
  FDA Approved: DIMETHYL FUMARATE — Supplemental Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s supplemental ANDA for a generic version of dimethyl fumarate. The product is indicated for relapsing forms of …

• FDA approval · 2024-10-01
  FDA Tentative Approval: FINGOLIMOD — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA issued tentative approval for a supplemental application for Fingolimod by XLCare Pharmaceuticals Inc., enabling a generic version to en…

• FDA approval · 2024-09-25
  FDA Approved: GLATIRAMER ACETATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' original Abbreviated New Drug Application for glatiramer acetate, a generic version of Copax…

• FDA approval · 2024-09-25
  FDA Approved: GLATIRAMER ACETATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original ANDA for glatiramer acetate, a generic version of the multiple sclerosis treatment.

• FDA approval · 2024-09-13
  FDA Approved: OCREVUS ZUNOVO — Original Application (Genentech, Inc.)

  FDA approved the original biologics license application for OCREVUS ZUNOVO (ocrelizumab and hyaluronidase) from Genentech. The product provi…

• FDA approval · 2024-09-11
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for VUMERITY (diroximel fumarate), updating/expanding its labeling for the treatment of multi…

• FDA approval · 2024-08-28
  FDA Approved: FINGOLIMOD — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for fingolimod filed by XLCare Pharmaceuticals Inc., indicating regulatory approval of a change …

• FDA approval · 2024-08-22
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for teriflunomide from Mylan Pharmaceuticals Inc., authorizing a generic product. Teriflunomide is u…

• FDA approval · 2024-08-07
  FDA Approved: TIZANIDINE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for a generic version of tizanidine from Rising Pharma Holdings, Inc., enabling marketing of the drug …

• FDA approval · 2024-06-26
  FDA Approved: DIMETHYL FUMARATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves the original ANDA for dimethyl fumarate by Macleods Pharmaceuticals Limited.

• FDA approval · 2024-06-21
  FDA Approved: OCREVUS — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Ocrevus (ocrelizumab) submitted by Genentech, Inc. This marks a supplemental approval of the dru…