Systemic Lupus Erythematosus

• EMA approval · 2026-07-16
  EMA Authorised: Benlysta (belimumab) — GlaxoSmithKline Trading Services Limited

  EMA authorised Benlysta (belimumab) for systemic lupus erythematosus.

• EMA approval · 2026-07-15
  EMA Authorised: Saphnelo (anifrolumab) — AstraZeneca AB

  EMA has authorised Saphnelo (anifrolumab) for systemic lupus erythematosus in Europe.

• EMA approval · 2026-01-28
  EMA Authorised: Saphnelo (anifrolumab) — AstraZeneca AB

  The European Medicines Agency authorised Saphnelo (anifrolumab) for systemic lupus erythematosus, expanding EU treatment options. The market…

• EMA approval · 2025-10-07
  EMA Authorised: Benlysta (belimumab) — GlaxoSmithKline Trading Services Limited

  The European Medicines Agency authorised Benlysta (belimumab) for systemic lupus erythematosus in the European Union.

• FDA approval · 2025-06-27
  FDA Approved: MYHIBBIN — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for MYHIBBIN (mycophenolate mofetil) submitted by Azurity Pharmaceuticals, Inc. The supplement perta…

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• FDA approval · 2025-06-20
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2025-06-13
  FDA Approved: HYDROXYCHLOROQUINE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for hydroxychloroquine (HYDROXYCHLOROQUINE) from Chartwell RX, LLC under an ANDA. The action upd…

• FDA approval · 2025-06-13
  FDA Approved: AZATHIOPRINE — Supplemental Application (Ascend Laboratories, LLC)

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

• FDA approval · 2025-02-13
  FDA Approved: PREDNISOLONE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental Abbreviated New Drug Application for a generic prednisolone product from PAI Holdings/PAI Pharma, signaling regu…

• FDA approval · 2024-12-26
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approves Slate Run Pharmaceuticals' original application for CYCLOPHOSPHAMIDE FOR INJECTION, expanding the market for a generic cyclopho…

• FDA approval · 2024-12-19
  FDA Approved: CYCLOPHOSPHAMIDE — Original Application (BluePoint Laboratories)

  FDA approved BluePoint Laboratories' original ANDA for cyclophosphamide, establishing a generic version of the chemotherapy agent.

• FDA approval · 2024-10-11
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

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

• FDA approval · 2024-05-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2024-05-16
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2024-05-16
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for BENLYSTA (belimumab) from GlaxoSmithKline, indicating an updated label or expanded indicatio…

• FDA approval · 2024-02-09
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental Biologics License Application for BENLYSTA (belimumab) by GlaxoSmithKline LLC, resulting in an updated indic…

• FDA approval · 2024-02-09
  FDA Approved: BENLYSTA — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2024-01-24
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate manufactured by Ipca Laboratories Limited. The approval updates the p…

• FDA approval · 2023-12-05
  FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)

  FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…

• FDA approval · 2023-12-01
  FDA Approved: SAPHNELO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  The FDA approved a supplemental application for SAPHNELO (anifrolumab-fnia) from AstraZeneca Pharmaceuticals LP.

• FDA approval · 2023-11-29
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for HYDROXYCHLOROQUINE SULFATE from Dr. Reddy's Laboratories Inc.

• FDA approval · 2023-09-14
  FDA Approved: SOVUNA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOVUNA (hydroxychloroquine sulfate) submitted by ANI Pharmaceuticals, under NDA 214581.

• FDA approval · 2023-05-05
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Sun Pharmaceutical Industries, Inc., updating the approval for t…

• FDA approval · 2023-03-30
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate filed by Teva Pharmaceuticals USA, Inc., marking an approved change u…

• 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.