Multiple Sclerosis

• FDA approval · 2020-08-14
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for dalfampridine from Sun Pharmaceutical Industries, Inc., indicating an approval related to th…

• FDA approval · 2020-08-13
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for teriflunomide from Glenmark Pharmaceuticals Inc., USA, enabling a generic version of the dru…

• FDA approval · 2020-08-13
  FDA Approved: BACLOFEN — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Baclofen from Endo USA, Inc. (ANDA077068).

• FDA approval · 2020-08-13
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for dalfampridine from Aurobindo Pharma Limited, indicating an approval action for this generic prod…

• FDA approval · 2020-07-31
  FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Mayzent (siponimod) submitted by Novartis Pharmaceuticals Corporation. The submission is for NDA…

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• FDA approval · 2020-07-22
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  FDA approved a supplemental application for COPAXONE (glatiramer acetate) by Teva Neuroscience, Inc., leading to changes to the drug’s label…

• FDA approval · 2020-07-18
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for teriflunomide from Alembic Pharmaceuticals Inc.

• FDA approval · 2020-07-09
  FDA Approved: BACLOFEN — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved an original application for a generic baclofen product from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2020-07-02
  FDA Approved: FINGOLIMOD — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved Teva's original application for a generic fingolimod product (ANDA 208008). Fingolimod is used to treat relapsing forms of …

• FDA approval · 2020-06-23
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic teriflunomide from Aurobindo Pharma Limited, enabling its marketing for multiple scler…

• FDA approval · 2020-06-22
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for teriflunomide from Mylan Pharmaceuticals Inc., enabling a generic version to be marketed.

• FDA approval · 2020-06-18
  FDA Approved: FINGOLIMOD — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's original application for fingolimod, allowing a generic version of the multiple sclerosis treatment to reach the mar…

• FDA approval · 2020-06-17
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA supplemental approval application submitted for TYSABRI (natalizumab) by Biogen; seeks regulatory action on an additional indication or …

• FDA approval · 2020-05-27
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Trifluent Pharma, LLC)

  FDA approved the original application for tizanidine hydrochloride from Trifluent Pharma, LLC as a generic drug.

• FDA approval · 2020-05-26
  FDA Approved: REBIF — Supplemental Application (EMD Serono, Inc.)

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

• FDA approval · 2020-05-18
  FDA Approved: FINGOLIMOD — Original Application (XLCare Pharmaceuticals Inc.)

  FDA approved Fingolimod from XLCare Pharmaceuticals Inc. as an original-application generic for relapsing forms of multiple sclerosis.

• FDA approval · 2020-05-14
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for COPAXONE (glatiramer acetate) submitted by Teva Neuroscience, Inc.

• FDA approval · 2020-03-27
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  FDA approved a supplemental application for Avonex (interferon beta-1a) by Biogen, resulting in a modification to the existing label.

• FDA approval · 2020-03-27
  FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for the PLEGRIDY PEN autoinjector, delivering peginterferon beta-1a for relapsing forms o…

• FDA approval · 2020-03-25
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Original Application (Celgene Corporation)

  FDA approved Zeposia 7-day starter pack containing ozanimod hydrochloride under the Original Application for Celgene Corporation. The starte…

• FDA approval · 2020-03-24
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of tizanidine hydrochloride from Aurobindo Pharma Limited via Original Application (ANDA 213544) for the trea…

• FDA approval · 2020-02-28
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for AUBAGIO (teriflunomide) submitted by Genzyme Corporation. This action updates the approved l…

• FDA approval · 2020-02-28
  FDA Approved: TERIFLUNOMIDE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original ANDA for teriflunomide by Mylan Pharmaceuticals, enabling the generic version to be marketed.

• FDA approval · 2020-02-09
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals’ supplemental application for teriflunomide (generic) under ANDA209572, enabling its marketing for mult…

• FDA approval · 2020-02-05
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TECFIDERA (dimethyl fumarate).