Rheumatoid Arthritis

• FDA approval · 2025-02-21
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) submitted by Pfizer, updating the extended-release formulation's label.

• FDA approval · 2025-02-18
  FDA Approved: OXAPROZIN — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Oxaprozin from Dr. Reddy's Laboratories Limited, indicating an approved change to the previously…

• FDA approval · 2025-02-15
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen (ANDA074190) from Hikma Pharmaceuticals USA Inc., resulting in an updated approval of t…

• 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 · 2025-01-07
  FDA Approved: NABUMETONE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original application for nabumetone, a nonsteroidal anti-inflammatory drug used to relieve pain in ost…

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• FDA approval · 2024-12-19
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for Aurobindo Pharma Limited's generic celecoxib.

• FDA approval · 2024-12-18
  FDA Approved: IDACIO — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for IDACIO (adalimumab-aacf) from Fresenius Kabi USA, LLC.

• FDA approval · 2024-12-17
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Leflunomide from Lupin Pharmaceuticals, Inc., indicating FDA approval of changes to this gen…

• FDA approval · 2024-11-22
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for Naproxen and Esomeprazole Magnesium (ANDA 213699), establishing a generic…

• FDA approval · 2024-11-22
  FDA Approved: RELAFEN DS — Supplemental Application (Carwin Pharmaceutical Associates, LLC)

  The FDA approved a supplemental application for Relafen DS (nabumetone) submitted by Carwin Pharmaceutical Associates, LLC.

• FDA approval · 2024-11-22
  FDA Approved: ETODOLAC — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for etodolac filed by Ipca Laboratories Limited. This represents regulatory clearance for this g…

• FDA approval · 2024-11-21
  FDA Approved: NABUMETONE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Nabumetone from Exelan Pharmaceuticals Inc., effectively updating its labeling under an existing…

• FDA approval · 2024-11-21
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA supplemental approval for tolmetin sodium under Atland Pharmaceuticals, LLC; the submission indicates a supplemental application proceed…

• FDA approval · 2024-11-21
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for diclofenac sodium and misoprostol from Mylan Pharmaceuticals Inc., updating the product's la…

• FDA approval · 2024-11-21
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for Tolmetin Sodium (generic tolmetin) from Atland Pharmaceuticals, LLC.

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

  The FDA approved a supplemental application for MELOXICAM from Zydus Pharmaceuticals USA Inc., as part of an ANDA, indicating approval of an…

• FDA approval · 2024-11-21
  FDA Approved: NABUMETONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Nabumetone.

• FDA approval · 2024-11-21
  FDA Approved: INDOMETHACIN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for indomethacin submitted by Chartwell RX, LLC. This action represents an approved supplement t…

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for MELOXICAM (meloxicam) under ANDA077944.

• FDA approval · 2024-11-21
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for a generic diclofenac sodium product from NorthStar Rx LLC.

• FDA approval · 2024-11-21
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Indomethacin from Amneal Pharmaceuticals LLC (ANDA 091549), authorizing a supplemental change to…

• FDA approval · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for Etodolac submitted by Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2024-11-21
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental ANDA for etodolac from Apotex Corp.

• FDA approval · 2024-11-21
  FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Celebrex (celecoxib) filed by Viatris Specialty LLC. The approval covers changes requested i…

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved a supplemental application for meloxicam from AiPing Pharmaceutical, Inc. The approval pertained to updating the labeling under…