Multiple Sclerosis

• FDA approval · 2010-09-21
  FDA Approved: GILENYA — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approves GILENYA (fingolimod hydrochloride) through an original application from Novartis Pharmaceuticals Corporation. The approval is f…

• FDA approval · 2010-04-27
  FDA Approved: BACLOFEN — Supplemental Application (Northstar RxLLC)

  The FDA approved a supplemental application for baclofen submitted by Northstar RxLLC. Baclofen is used to reduce muscle spasticity in condi…

• FDA approval · 2010-01-22
  FDA Approved: AMPYRA — Original Application (Merz Pharmaceuticals, LLC)

  FDA approved AMPYRA (dalfampridine) through its Original Application submitted by Merz Pharmaceuticals for improving walking in adults with …

• FDA approval · 2010-01-21
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for TYSABRI (Natalizumab) from Biogen Inc. The approval updates the drug's label and indications…

• FDA approval · 2009-10-26
  FDA Approved: KESIMPTA — Original Application (Novartis Pharmaceuticals Corporation)

  The FDA approved Kesimpta (ofatumumab) under an original Biologics License Application from Novartis for the treatment of relapsing forms of…

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• FDA approval · 2009-09-18
  FDA Approved: BACLOFEN — Original Application (Northstar RxLLC)

  FDA approved the original ANDA for generic baclofen from Northstar RxLLC. This approval authorizes the generic product for treating spastici…

• FDA approval · 2009-04-03
  FDA Approved: BACLOFEN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for Baclofen (BACLOFEN), updating the existing approval for the drug.

• FDA approval · 2009-04-03
  FDA Approved: BACLOFEN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for baclofen (generic), indicating an approval related to the product's labeling or formula…

• FDA approval · 2009-03-26
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved Bayer HealthCare Pharmaceuticals Inc.'s supplemental application for Betaseron (interferon beta-1b). The approval relates to th…

• FDA approval · 2009-02-27
  FDA Approved: COPAXONE — Supplemental Application (Teva Neuroscience, Inc.)

  The FDA approved a supplemental application for Copaxone (glatiramer acetate) submitted by Teva Neuroscience, Inc., related to changes to th…

• FDA approval · 2008-09-08
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Betaseron (interferon beta-1b) from Bayer HealthCare Pharmaceuticals, resulting in an approved m…

• FDA approval · 2008-08-25
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), updating its labeling and/or indication.

• FDA approval · 2008-08-13
  FDA Approved: BACLOFEN — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for baclofen submitted by Chartwell RX, LLC under ANDA 077241.

• FDA approval · 2008-08-12
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TYSABRI (natalizumab).

• FDA approval · 2008-04-02
  FDA Approved: TIZANIDINE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. to market a generic version of tizanidine.

• FDA approval · 2007-06-20
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  FDA approves Biogen's supplemental Biologics License Application for AVONEX (interferon beta-1a).

• FDA approval · 2007-04-26
  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 appro…

• FDA approval · 2007-03-22
  FDA Approved: TIZANIDINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for tizanidine from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2007-02-07
  FDA Approved: TIZANIDINE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for tizanidine submitted by Dr. Reddy's Laboratories Limited. The approval indicates regulatory clea…

• FDA approval · 2007-02-02
  FDA Approved: AVONEX — Supplemental Application (Biogen Inc.)

  The FDA approved a supplemental application for Avonex (interferon beta-1a) submitted by Biogen Inc.

• FDA approval · 2006-11-09
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved Bayer's supplemental application for BETASERON (interferon beta-1b), updating the product's labeling.

• FDA approval · 2006-10-20
  FDA Approved: BETASERON — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for BETASERON (interferon beta-1B) by Bayer HealthCare Pharmaceuticals Inc., resulting in changes to…

• FDA approval · 2006-07-28
  FDA Approved: ZANAFLEX — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental NDA for ZANAFLEX (tizanidine hydrochloride) submitted by Covis Pharma US, Inc., resulting in updated labelin…

• FDA approval · 2006-07-28
  FDA Approved: ZANAFLEX — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for ZANAFLEX (tizanidine hydrochloride) submitted by Covis Pharma US, Inc.

• FDA approval · 2006-06-05
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), resulting in an approved change to the product's labeling/auth…