Juvenile Idiopathic Arthritis

• 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: 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: 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.

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• 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…

• 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.

• FDA approval · 2024-09-27
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

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

• FDA approval · 2024-08-26
  FDA Approved: ADALIMUMAB-RYVK — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for ADALIMUMAB-RYVK, a biosimilar to adalimumab, submitted by Quallent Pharmaceuticals Health LL…

• FDA approval · 2024-06-03
  FDA Approved: METHOTREXATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for methotrexate, authorizing the generic version of the drug.

• FDA approval · 2024-05-14
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ (tofacitinib) from Pfizer, granting an additional regulatory action under NDA 213082.

• FDA approval · 2024-04-30
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ABRILADA (adalimumab-afzb) from Pfizer Laboratories Div Pfizer Inc, authorizing its use as a…

• FDA approval · 2024-02-22
  FDA Approved: ZYMFENTRA — Supplemental Application (CELLTRION USA Inc.)

  The FDA approved a supplemental application for ZYMFENTRA (infliximab-dyyb) submitted by Celltrion USA Inc.

• FDA approval · 2023-12-28
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for MELOXICAM (meloxicam).

• FDA approval · 2023-12-26
  FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.

• FDA approval · 2023-12-15
  FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)

  The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).

• FDA approval · 2023-11-21
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals, incorporating changes to the a…

• FDA approval · 2023-11-03
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…

• FDA approval · 2023-10-18
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2023-10-06
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-09-21
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…

• FDA approval · 2023-08-31
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for tolmetin sodium from Atland Pharmaceuticals, LLC. This action approves changes under an appr…