Osteoarthritis

• FDA approval · 2026-03-17
  FDA Approved: PIROXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for piroxicam from Unichem Pharmaceuticals (USA), Inc., for the generic product.

• FDA approval · 2025-10-03
  FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)

  FDA approved Naproxen from Aurobindo Pharma Limited as an original generic application (ANDA 216504). Naproxen is a nonsteroidal anti-inflam…

• FDA approval · 2025-09-26
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for diclofenac sodium topical gel 1% from BluePoint Laboratories, authorizing its marketing as a gen…

• FDA approval · 2025-07-29
  FDA Approved: VYSCOXA — Original Application (Carwin Pharmaceutical Associates, LLC)

  FDA approved VYSCOXA, a brand name for celecoxib, under Carwin Pharmaceutical Associates, LLC's original application. This confirms marketin…

• FDA approval · 2025-06-05
  FDA Approved: XIFYRM — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved XIFYRM (meloxicam) under an original application by Azurity Pharmaceuticals, Inc., establishing a new branded meloxicam product…

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• FDA approval · 2025-03-21
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Naproxen and Esomeprazole Magnesium from Dr. Reddy's Laboratories Limited. This approval confirm…

• FDA approval · 2025-02-27
  FDA Approved: DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Diclofenac Sodium/Misoprostol (Diclofenac-Sodium-Misoprostol) from Micro Labs Limited.

• FDA approval · 2025-02-26
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for Celecoxib (celecoxib), authorizing a generic version under the ANDA pathway. The ac…

• FDA approval · 2025-02-24
  FDA Approved: INDOMETHACIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's original application for Indomethacin, authorizing a generic version of the NSAID with the same…

• 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 · 2025-01-07
  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…

• 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 · 2024-12-03
  FDA Approved: ZILRETTA — Supplemental Application (Pacira Pharmaceuticals, Inc.)

  FDA approves a supplemental application for ZILRETTA, an extended-release intra-articular corticosteroid, submitted by Pacira Pharmaceutical…

• 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: DICLOFENAC SODIUM 1.5% — Supplemental Application (SOLA Pharmaceuticals)

  FDA approved a supplemental application for diclofenac sodium topical 1.5% from SOLA Pharmaceuticals, indicating an approved change related …

• 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…