Systemic Lupus Erythematosus

• FDA approval · 2016-12-02
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Benlysta (belimumab) from GlaxoSmithKline LLC.

• FDA approval · 2016-08-01
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for the generic drug Mycophenolate mofetil from Strides Pharma Science Limited, finalizing changes t…

• FDA approval · 2015-11-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application from Ascend Laboratories, LLC for Mycophenolate mofetil (ANDA 200197).

• FDA approval · 2015-11-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for mycophenolate mofetil from Ascend Laboratories, LLC.

• FDA approval · 2015-11-13
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application to allow Strides Pharma Science Limited to market a generic mycophenolate mofetil. This approval…

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• FDA approval · 2015-10-30
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for mycophenolate mofetil filed by Mylan Pharmaceuticals Inc. The action relates to the approved gen…

• FDA approval · 2015-07-09
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CellCept (mycophenolate mofetil) submitted by Genentech, Inc.

• FDA approval · 2015-06-01
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Mycophenolate mofetil from Accord Healthcare Inc., updating the approved generic product.

• FDA approval · 2015-01-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Aurobindo Pharma Limited.

• FDA approval · 2014-10-25
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica, Inc. to market a generic cyclophosphamide product.

• FDA approval · 2014-04-03
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BENLYSTA (belimumab) submitted by GlaxoSmithKline LLC. This action updates the product labeling …

• FDA approval · 2013-12-13
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for BENLYSTA (belimumab) filed by GlaxoSmithKline LLC, enabling a label change or expanded use for s…

• FDA approval · 2013-09-27
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Sandoz Inc's mycophenolate mofetil.

• FDA approval · 2012-09-25
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for mycophenolate mofetil, the generic immunosuppressant, via Teva Pharmaceuticals USA, Inc. This ac…

• FDA approval · 2012-09-25
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for mycophenolate mofetil submitted by Mylan Pharmaceuticals Inc. The action updates the product's l…

• FDA approval · 2012-07-25
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., resulting in changes to the approved …

• FDA approval · 2012-03-30
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for BENLYSTA (belimumab) from GlaxoSmithKline LLC.

• FDA approval · 2011-03-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., under an existing ANDA. This action confirms the…

• FDA approval · 2011-03-09
  FDA Approved: BENLYSTA — Original Application (GlaxoSmithKline LLC)

  FDA approved Benlysta (belimumab) from GlaxoSmithKline LLC as the original application for treatment of systemic lupus erythematosus.

• FDA approval · 2010-02-02
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Mycophenolate mofetil submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2009-11-30
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic mycophenolate mofetil. The product is used to prevent organ transpla…

• FDA approval · 2009-09-09
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for mycophenolate mofetil submitted by Hikma Pharmaceuticals USA Inc., updating the labeling for…

• FDA approval · 2008-02-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Teva Pharmaceuticals USA, Inc. The action represents an …

• FDA approval · 2007-12-20
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.

• FDA approval · 2007-09-21
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Zydus Lifesciences Limited)

  FDA approves the original ANDA for hydroxychloroquine sulfate, a generic version manufactured by Zydus Lifesciences Limited.