Multiple Sclerosis

• FDA approval · 2022-09-02
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for BETASERON (interferon beta-1b) from Bayer HealthCare Pharmaceuticals Inc., resulting in an updat…

• FDA approval · 2022-09-02
  FDA Approved: KESIMPTA — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA has approved a supplemental application for Kesimpta (ofatumumab) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2022-08-19
  FDA Approved: GLATIRAMER ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for glatiramer acetate from Mylan Pharmaceuticals, enabling the marketing of a generic version o…

• FDA approval · 2022-08-19
  FDA Approved: GLATIRAMER ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for glatiramer acetate from Mylan Pharmaceuticals Inc., indicating approval of a generic version…

• FDA approval · 2022-07-28
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for dalfampridine from Sun Pharmaceutical Industries, Inc. (ANDA208292), supporting the generic …

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• FDA approval · 2022-07-15
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Teriflunomide from Teva Pharmaceuticals, Inc. This action indicates FDA approval of a supple…

• FDA approval · 2022-07-15
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare Inc.'s Teriflunomide, finalizing regulatory action on the generic product.

• FDA approval · 2022-06-10
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2022-06-10
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic tizanidine hydrochloride product submitted by Alembic Pharmaceuticals Limited unde…

• FDA approval · 2022-06-10
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Tizanidine Hydrochloride from Aurobindo Pharma Limited under an ANDA. This action confirms regul…

• FDA approval · 2022-05-25
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for tizanidine hydrochloride submitted by Zydus Lifesciences Limited. This action completes FDA appr…

• FDA approval · 2022-05-25
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for tizanidine hydrochloride by Nivagen Pharmaceuticals, Inc., representing a regulatory update for …

• FDA approval · 2022-04-15
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approves a supplemental application for COPAXONE (glatiramer acetate) by Teva Neuroscience, expanding the labeling.

• FDA approval · 2022-03-29
  FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for Plegridy Pen, the autoinjector device for peginterferon beta-1a, for use in treating …

• FDA approval · 2022-03-01
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2022-02-10
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for Tecfidera (dimethyl fumarate) from Biogen Inc. This action relates to an additional regulatory s…

• FDA approval · 2022-02-10
  FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for VUMERITY (diroximel fumarate), updating its labeling.

• FDA approval · 2022-02-04
  FDA Approved: BACLOFEN — Original Application (Wilshire Pharmaceuticals, Inc.)

  The FDA approved an Original Application for baclofen by Wilshire Pharmaceuticals, authorizing its use for treating spasticity.

• FDA approval · 2022-01-28
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for COPAXONE, a glatiramer acetate product, manufactured by Teva Neuroscience, Inc.

• FDA approval · 2022-01-25
  FDA Approved: BACLOFEN — Original Application (Major Pharmaceuticals)

  FDA approved a generic baclofen under an Original Application from Major Pharmaceuticals.

• FDA approval · 2021-12-23
  FDA Approved: TASCENSO ODT — Original Application (Cycle Pharmaceuticals Ltd)

  FDA approved TASCENSO ODT (fingolimod lauryl sulfate) through an Original Application by Cycle Pharmaceuticals Ltd for the treatment of mult…

• FDA approval · 2021-11-22
  FDA Approved: LYVISPAH — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved LYVISPAH (baclofen) from Amneal Pharmaceuticals LLC as an Original Application. It is indicated for the management of spasticit…

• FDA approval · 2021-11-10
  FDA Approved: FINGOLIMOD — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma's original application for fingolimod hydrochloride (Fingolimod HCl), a generic version of the MS drug fingol…

• FDA approval · 2021-11-03
  FDA Approved: REBIF — Supplemental Application (EMD Serono, Inc.)

  The FDA approved a supplemental application for Rebif (interferon beta-1a) submitted by EMD Serono, Inc.

• FDA approval · 2021-11-03
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for AVONEX (interferon beta-1a).