Rheumatoid Arthritis

• FDA approval · 2019-06-03
  FDA Approved: LEFLUNOMIDE — Original Application (KVK-Tech, Inc.)

  FDA approves Leflunomide from KVK-Tech, Inc. via an Original Application (ANDA 212453). The product is indicated for rheumatoid arthritis.

• FDA approval · 2019-05-23
  FDA Approved: TRUXIMA — Supplemental Application (Cephalon, Inc.)

  FDA approved a supplemental application for TRUXIMA (rituximab-ABBS) submitted by Cephalon, Inc.

• FDA approval · 2019-05-06
  FDA Approved: DICLOFENAC SODIUM — Original Application (Harris Teeter)

  FDA approved Harris Teeter's diclofenac sodium as a generic under an original ANDA.

• FDA approval · 2019-05-03
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Daypro (oxaprozin) from Pfizer Laboratories Div Pfizer Inc, advancing regulatory action rela…

• FDA approval · 2019-04-24
  FDA Approved: LEFLUNOMIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic Leflunomide tablet from Zydus Lifesciences Limited under an Original Application (ANDA212308).

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• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for azathioprine from Zydus Lifesciences Limited.

• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., confirming a new generic form of the drug.

• FDA approval · 2019-03-21
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) submitted by E.R. Squibb & Sons, L.L.C., indicating a labeling change and/or…

• FDA approval · 2019-02-21
  FDA Approved: PREDNISONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prednisone from Mylan Pharmaceuticals, indicating approval of an existing generic product's …

• FDA approval · 2019-01-15
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic hydroxychloroquine sulfate product under an Original Application from Rising Pharma Holdings, Inc. for use in tre…

• FDA approval · 2018-11-30
  FDA Approved: ETODOLAC — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's etodolac as a generic (ANDA 209888) for relief of signs and symptoms of osteoarthritis and rheumatoid a…

• FDA approval · 2018-11-29
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., confirming regulatory clearance for an updated product-rel…

• FDA approval · 2018-10-30
  FDA Approved: ADALIMUMAB — Original Application (Sandoz Inc)

  FDA approved the original application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc. The approval covers the same indication…

• FDA approval · 2018-10-16
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2018-10-03
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation. The approval updates the labeling as descr…

• FDA approval · 2018-09-12
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA has approved a supplemental application for Actemra (tocilizumab) submitted by Genentech, Inc. The approval updates the labeling/indicat…

• FDA approval · 2018-07-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved Bayer's supplemental application to add ALEVE GELCAPS (naproxen sodium) as an additional formulation of naproxen products.

• FDA approval · 2018-07-06
  FDA Approved: HYDROXYCHLOROQUINE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for a generic hydroxychloroquine product (ANDA210543) developed by Chartwell RX, LLC.

• FDA approval · 2018-06-07
  FDA Approved: ETODOLAC — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved the original ANDA for etodolac from Amneal Pharmaceuticals NY LLC, enabling the marketing of a generic etodolac product.

• FDA approval · 2018-05-31
  FDA Approved: OLUMIANT — Original Application (Eli Lilly and Company)

  This FDA page confirms the original approval of Olumiant (baricitinib) by Eli Lilly for rheumatoid arthritis, marking the first FDA approval…

• FDA approval · 2018-05-25
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation. The approval pertains to the supplement to…

• FDA approval · 2018-05-15
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic hydroxychloroquine sulfate product from Amneal Pharmaceuticals NY LLC under an original application.

• FDA approval · 2018-05-11
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation. The action updates the drug's labeling…

• FDA approval · 2018-05-08
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved hydroxychloroquine sulfate as a generic drug under an Original Application (ANDA201691) for Sun Pharmaceutical Industries, Inc.

• FDA approval · 2018-05-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original ANDA for hydroxychloroquine sulfate (generic) from Dr. Reddy's Laboratories Inc. This approval authorizes marketin…