Rheumatoid Arthritis

• 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 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.

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• EMA approval · 2024-10-24
  EMA Authorised: Jylamvo (methotrexate) — Oresund Pharma ApS

  The European Medicines Agency authorised Jylamvo, a methotrexate product from Oresund Pharma ApS, for indications including psoriatic arthri…

• FDA approval · 2024-10-23
  FDA Approved: JYLAMVO — Supplemental Application (SHORLA ONCOLOGY INC.)

  The FDA approved a supplemental application for JYLAMVO (methotrexate) filed by SHORLA ONCOLOGY INC.

• FDA approval · 2024-10-11
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Aurobindo Pharma Limited.

• 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 · 2024-09-26
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Leflunomide submitted by Apotex Corp. under the existing Leflunomide approval.

• FDA approval · 2024-09-26
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Leflunomide submitted by Zydus Lifesciences Limited.

• FDA approval · 2024-09-26
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application from Aurobindo Pharma Limited for Leflunomide (generic).

• FDA approval · 2024-09-23
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Leflunomide from Alembic Pharmaceuticals Limited, confirming continued approval of the generic p…

• 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 · 2024-08-16
  FDA Approved: DIFLUNISAL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental abbreviated new drug application for DIFLUNISAL (diflunisal) from Heritage Pharmaceuticals d/b/a Avet Pharma…

• FDA approval · 2024-08-01
  FDA Approved: ETODOLAC — Original Application (Ipca Laboratories Limited)

  FDA approved the etodolac generic product from Ipca Laboratories Limited under an original application (ANDA).

• FDA approval · 2024-07-29
  FDA Approved: BROMFENAC — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's bromfenac as a generic under Original Application ANDA210962. Bromfenac is approved as an N…

• FDA approval · 2024-07-26
  FDA Approved: FENOPRON TM — Supplemental Application (Galt Pharmaceuticals, LLC)

  FDA approves a supplemental application for Fenoprofen calcium (FENOPRON TM) by Galt Pharmaceuticals, LLC, to update the product labeling.

• FDA approval · 2024-06-28
  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. This action updates the regulatory sta…

• FDA approval · 2024-06-14
  FDA Approved: DICLOFENAC POTASSIUM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a generic diclofenac potassium tablet from Taro Pharmaceuticals U.S.A., Inc. under an original ANDA for relief of pain in sever…

• FDA approval · 2024-06-10
  FDA Approved: KEVZARA — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for KEVZARA (sarilumab) submitted by Sanofi-Aventis U.S. LLC.

• 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 · 2024-05-21
  FDA Approved: CYCLOSPORINE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s cyclosporine as a generic drug under an original ANDA (ANDA209811).

• FDA approval · 2024-05-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Amneal Pharmaceuticals NY LLC.

• 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.