Systemic Lupus Erythematosus

• FDA label_change · 2024-10-10
  FDA Approved: SOVUNA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOVUNA (hydroxychloroquine sulfate) by ANI Pharmaceuticals, Inc., indicating a label change.

• FDA label_change · 2024-08-13
  FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Biocon Pharma Inc.)

  FDA approved a supplemental application for Mycophenolic acid filed by Biocon Pharma Inc., updating the labeling for the product.

• FDA label_change · 2024-08-07
  FDA Approved: SAPHNELO — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SAPHNELO (ANIFROLUMAB-FNIA) from AstraZeneca Pharmaceuticals LP. The action pertains to a labeli…

• FDA label_change · 2023-05-10
  FDA Approved: METHYLPREDNISOLONE ACETATE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for methylprednisolone acetate by Sandoz Inc.

• FDA label_change · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA issued a supplemental approval for mycophenolate mofetil (Hikma) to update the drug's labeling under an existing approval.

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• FDA label_change · 2020-03-31
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Ipca Laboratories Limited, resulting in changes to the drug's la…