Multiple Sclerosis

• FDA approval · 2019-12-27
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for COPAXONE (glatiramer acetate) from Teva Neuroscience, Inc., indicating regulatory action on …

• FDA approval · 2019-12-26
  FDA Approved: GILENYA — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2019-12-11
  FDA Approved: TECFIDERA — Supplemental Application (Biogen Inc.)

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

• FDA approval · 2019-12-04
  FDA Approved: FINGOLIMOD — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's original application for fingolimod (generic) for relapsing forms of multiple sclerosis.

• FDA approval · 2019-12-04
  FDA Approved: FINGOLIMOD — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved fingolimod as an original application (generic) submitted by Quallent Pharmaceuticals Health LLC.

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• FDA approval · 2019-11-29
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic version of teriflunomide, manufactured by Aurobindo Pharma Limited (ANDA 209638).

• FDA approval · 2019-11-29
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for teriflunomide by Glenmark Pharmaceuticals Inc., USA. Teriflunomide is a disease-modifying therap…

• FDA approval · 2019-10-29
  FDA Approved: VUMERITY — Original Application (Biogen Inc.)

  The FDA approved Biogen's VUMERITY (diroximel fumarate) through its original NDA (NDA 211855). This approval supports use of diroximel fumar…

• FDA approval · 2019-09-27
  FDA Approved: DALFAMPRIDINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application from Aurobindo Pharma Limited for dalfampridine, enabling the generic product to be marketed in …

• FDA approval · 2019-09-18
  FDA Approved: BACLOFEN — Original Application (Palmetto Pharmaceuticals Inc.)

  FDA records an original application approval for Baclofen submitted by Palmetto Pharmaceuticals Inc. The document marks the approval of a Ba…

• FDA approval · 2019-09-11
  FDA Approved: BACLOFEN (INTRATHECAL) — Original Application (MAIA Pharmaceuticals, Inc.)

  FDA approved an original application for a generic intrathecal baclofen product from MAIA Pharmaceuticals, enabling marketing of intrathecal…

• FDA approval · 2019-09-06
  FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)

  The FDA approved Genzyme's supplemental application for Aubagio (teriflunomide), resulting in changes to the drug's labeling.

• FDA approval · 2019-07-30
  FDA Approved: BACLOFEN — Original Application (Sagent Pharmaceuticals)

  FDA approved baclofen from Sagent Pharmaceuticals under an original ANDA, confirming the availability of generic baclofen for treating muscl…

• FDA approval · 2019-07-12
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for AVONEX (interferon beta-1a) submitted by Biogen Inc. This action updates the regulatory stat…

• FDA approval · 2019-07-10
  FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for PLEGRIDY PEN, the autoinjector device for peginterferon beta-1a, to be used in the treatment…

• FDA approval · 2019-07-09
  FDA Approved: REBIF — Supplemental Application (EMD Serono, Inc.)

  FDA approved a supplemental application for REBIF (interferon beta-1a) submitted by EMD Serono, Inc., indicating an approved update to its l…

• FDA approval · 2019-05-21
  FDA Approved: DALFAMPRIDINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's generic dalfampridine (Dalfampridine) for improving walking in adults with multiple sclerosis through an O…

• FDA approval · 2019-04-24
  FDA Approved: TERIFLUNOMIDE — Original Application (MSN LABORATORIES PRIVATE LIMITED)

  FDA approved the original application for a generic teriflunomide from MSN Laboratories Private Limited, indicated for relapsing forms of mu…

• FDA approval · 2019-04-23
  FDA Approved: CAMPATH — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for CAMPATH (alemtuzumab) submitted by Genzyme Corporation.

• FDA approval · 2019-04-19
  FDA Approved: TERIFLUNOMIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves the original application for Teriflunomide, a generic version manufactured by Alembic Pharmaceuticals Inc.

• FDA approval · 2019-03-29
  FDA Approved: MAVENCLAD — Original Application (EMD Serono, Inc.)

  The FDA approved MAVENCLAD (cladribine) under its original application for the treatment of multiple sclerosis.

• FDA approval · 2019-03-27
  FDA Approved: TIZANIDNE HYDROCHLORIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved Tizanidine Hydrochloride as an original generic drug application for the management of spasticity in adults with multiple scler…

• FDA approval · 2019-03-26
  FDA Approved: MAYZENT — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approves Mayzent (siponimod) from Novartis Pharmaceuticals Corporation in an original NDA for the treatment of relapsing forms of multip…

• FDA approval · 2019-03-26
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for tizanidine hydrochloride from Nivagen Pharmaceuticals, Inc.

• FDA approval · 2019-03-12
  FDA Approved: TIZANIDINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' original application for a generic tizanidine hydrochloride product.