Systemic Lupus Erythematosus

• FDA approval · 2023-02-15
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2022-11-16
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited.

• FDA approval · 2022-07-26
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2022-07-11
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.

• FDA approval · 2022-07-07
  FDA Approved: HYDROXYCHLOROQUINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for HYDROXYCHLOROQUINE from Chartwell RX, LLC under an ANDA, making a generic version available.

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• FDA approval · 2022-05-03
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for Plaquenil (hydroxychloroquine sulfate) submitted by Advanz Pharma (US) Corp. This action constit…

• FDA approval · 2022-01-14
  FDA Approved: SOVUNA — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved SOVUNA (hydroxychloroquine sulfate) under an original application by ANI Pharmaceuticals, Inc.

• FDA approval · 2021-10-22
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2021-09-14
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2021-08-23
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for hydroxychloroquine sulfate from Ipca Laboratories Limited, approving changes to an already-a…

• FDA approval · 2021-08-11
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2021-08-11
  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 product info…

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Mycophenolate mofetil from Mylan Pharmaceuticals Inc., updating the regulatory status for th…

• FDA approval · 2021-07-30
  FDA Approved: SAPHNELO — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved SAPHNELO (anifrolumab-fnia) from AstraZeneca in its original application for adults with moderate to severe systemic lupus eryt…

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., updating or expanding its labeled ind…

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  FDA approved a supplemental application for mycophenolic acid from Slate Run Pharmaceuticals, LLC.

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Archis Pharma LLC)

  The FDA approved Archis Pharma LLC's supplemental application for mycophenolic acid (generic), indicating an approved modification to the ma…

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Mycophenolate mofetil (Sandoz Inc), signaling an updated/expanded use or labeling for the produc…

• FDA approval · 2021-01-07
  FDA Approved: AZATHIOPRINE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for azathioprine sodium from Hikma Pharmaceuticals USA Inc., updating the generic product's approval…

• FDA approval · 2020-12-16
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2020-12-16
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  The U.S. FDA has approved a supplemental application for Belimumab (Benlysta) from GlaxoSmithKline LLC.

• FDA approval · 2020-08-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for mycophenolate mofetil, a generic immunosuppressant used to prevent organ transplant rejecti…

• FDA approval · 2020-04-09
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.

• FDA approval · 2020-04-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Aurobindo Pharma Limited.