Systemic Lupus Erythematosus

• FDA approval · 2020-04-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Creekwood Pharmaceuticals LLC)

  The FDA approved Creekwood Pharmaceuticals LLC's supplemental application for hydroxychloroquine sulfate, authorizing the continued marketin…

• FDA approval · 2020-01-17
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BENLYSTA (belimumab) submitted by GlaxoSmithKline LLC.

• FDA approval · 2020-01-17
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Benlysta (belimumab) filed by GlaxoSmithKline, resulting in an update to the product’s labeling.

• FDA approval · 2019-11-27
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for mycophenolate mofetil submitted by Hikma Pharmaceuticals USA Inc. The approval may involve label…

• FDA approval · 2019-11-22
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for mycophenolate mofetil submitted by Strides Pharma Science Limited, enabling regulatory updat…

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• FDA approval · 2019-11-15
  FDA Approved: PREDNISONE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approves ANI Pharmaceuticals' original (generic) application for prednisone, enabling a generic prednisone product to be marketed.

• FDA approval · 2019-09-13
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2019-09-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolate mofetil. This action updates the regulatory status for th…

• FDA approval · 2019-04-26
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2019-04-26
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approves a supplemental application for Belimumab (Benlysta) submitted by GlaxoSmithKline.

• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for azathioprine from Zydus Lifesciences Limited.

• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., confirming a new generic form of the drug.

• FDA approval · 2019-02-21
  FDA Approved: PREDNISONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prednisone from Mylan Pharmaceuticals, indicating approval of an existing generic product's …

• FDA approval · 2019-01-18
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s original application for a generic cyclophosphamide product. This marks approval of a generic formulation …

• FDA approval · 2019-01-15
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic hydroxychloroquine sulfate product under an Original Application from Rising Pharma Holdings, Inc. for use in tre…

• FDA approval · 2018-08-23
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CellCept (mycophenolate mofetil) filed by Genentech, Inc. The approval updates the labeling and/…

• FDA approval · 2018-07-06
  FDA Approved: HYDROXYCHLOROQUINE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for a generic hydroxychloroquine product (ANDA210543) developed by Chartwell RX, LLC.

• FDA approval · 2018-06-22
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BENLYSTA (belimumab) filed by GlaxoSmithKline LLC.

• FDA approval · 2018-06-22
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for BENLYSTA (belimumab) submitted by GlaxoSmithKline LLC.

• FDA approval · 2018-05-15
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic hydroxychloroquine sulfate product from Amneal Pharmaceuticals NY LLC under an original application.

• FDA approval · 2018-05-08
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved hydroxychloroquine sulfate as a generic drug under an Original Application (ANDA201691) for Sun Pharmaceutical Industries, Inc.

• FDA approval · 2018-05-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original ANDA for hydroxychloroquine sulfate (generic) from Dr. Reddy's Laboratories Inc. This approval authorizes marketin…

• FDA approval · 2017-07-20
  FDA Approved: BENLYSTA — Original Application (GlaxoSmithKline LLC)

  FDA granted original approval for BENLYSTA (belimumab) by GlaxoSmithKline LLC for systemic lupus erythematosus.

• FDA approval · 2017-01-27
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for Plaquenil (hydroxychloroquine sulfate) from Advanz Pharma (US) Corp.

• FDA approval · 2017-01-18
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BENLYSTA (belimumab) submitted by GlaxoSmithKline LLC. The snippet does not specify the exact ch…