Rheumatoid Arthritis

• FDA label_change · 2025-12-10
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) submitted by Genentech, Inc., related to changes to the product labeling.

• FDA label_change · 2025-03-26
  FDA Approved: RINVOQ — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie’s supplemental application for Rinvoq (upadacitinib), resulting in a labeling update for the product.

• FDA label_change · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Etodolac from ANI Pharmaceuticals, updating the labeling for this generic product.

• FDA label_change · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Etodolac by Zydus Pharmaceuticals USA Inc., resulting in labeling updates for this NSAID.

• FDA label_change · 2024-11-21
  FDA Approved: SULINDAC — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental labeling change for sulindac from Actavis Pharma, updating the product labeling under the ANDA. This reflects ad…

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• FDA label_change · 2024-11-21
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental labeling application for DAYPRO (oxaprozin) submitted by Pfizer Laboratories Div Pfizer Inc.

• 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 · 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 · 2023-02-28
  FDA Approved: KEVZARA — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for KEVZARA (sarilumab), resulting in changes to the product label.

• 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…

• FDA label_change · 2019-12-26
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  FDA approved a supplemental application for OTREXUP (methotrexate) from Antares Pharma, Inc., leading to changes in the labeling for this su…

• FDA label_change · 2017-06-22
  FDA Approved: RITUXAN HYCELA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Rituxan Hycela (rituximab and hyaluronidase) by Genentech, updating the labeling for this subcut…

• FDA label_change · 2016-09-13
  FDA Approved: CELECOXIB — Supplemental Application (Cipla USA Inc.)

  FDA Approved: CELECOXIB — Supplemental Application (Cipla USA Inc.) indicating a labeling modification related to celecoxib.

• FDA label_change · 2016-05-09
  FDA Approved: DIFLUNISAL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for DIFLUNISAL (diflunisal) from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., indi…

• FDA label_change · 2016-01-08
  FDA Approved: SIMPONI ARIA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for SIMPONI ARIA (golimumab) to update the product labeling.

• FDA label_change · 2015-08-05
  FDA Approved: SIMPONI ARIA — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Simponi Aria (golimumab) filed by Janssen Biotech, Inc., resulting in changes to the product lab…

• FDA label_change · 2015-04-01
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for DICLOFENAC SODIUM AND MISOPROSTOL from Mylan Pharmaceuticals, updating the labeling for this dic…

• FDA label_change · 2015-02-25
  FDA Approved: SULFASALAZINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for sulfasalazine from Teva Pharmaceuticals USA, updating the product labeling.

• FDA label_change · 2012-11-02
  FDA Approved: ARAVA — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for ARAVA (leflunomide) submitted by Sanofi-aventis U.S. LLC.