Osteoarthritis

• 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 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 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.

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• 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 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 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 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…

• 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: DICLOFENAC SODIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Diclofenac Sodium Topical from Alembic Pharmaceuticals Limited.

• 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…

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

  FDA has approved a supplemental application for NABUMETONE submitted by Chartwell RX, LLC. The action updates an existing approved ANDA for …

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

  The FDA approved a supplemental application for Nabumetone submitted by Actavis Pharma, Inc., representing a regulatory change to the existi…

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

  FDA approved Lupin Pharmaceuticals' supplemental application for meloxicam, confirming regulatory clearance for the product.

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

  The FDA approved a supplemental application for MELOXICAM from Cipla USA Inc., authorizing changes to an existing meloxicam product under an…

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

  The FDA approved a supplemental application for ibuprofen from Actavis Pharma, Inc.

• CLINICAL_TRIALS research · 2024-11-15
  Clinical Trial Update: The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis [Phase 2]

  Phase 2 trial evaluating the combined use of platelet-rich plasma with liposuction-derived adipose tissue and/or bone marrow aspirate for os…