Psoriatic Arthritis

• FDA approval · 2019-07-23
  FDA Approved: HADLIMA — Original Application (Organon LLC)

  FDA approves Hadlima (adalimumab-bwwd) from Organon as a biosimilar to Humira under the original application BLA761059. It is indicated for …

• FDA approval · 2019-06-13
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  The FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• 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 · 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.

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• 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 · 2018-06-08
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab submitted by Janssen Biotech, Inc.

• 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 · 2018-05-11
  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 · 2018-03-20
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Cimzia (certolizumab pegol) filed by UCB, Inc.

• FDA approval · 2018-03-15
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2018-02-09
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for SIMPONI (golimumab) submitted by Janssen Biotech, Inc.

• FDA approval · 2017-12-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) filed by Pfizer Laboratories Div Pfizer Inc, enabling the extended-rele…

• FDA approval · 2017-12-01
  FDA Approved: TALTZ — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for TALTZ (ixekizumab) submitted by Eli Lilly and Company, resulting in an expanded label for additi…

• FDA approval · 2017-10-13
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., potentially expanding indications or updat…

• FDA approval · 2017-06-30
  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. This action updates the product labe…

• FDA approval · 2017-06-22
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Simponi (golimumab) submitted by Janssen Biotech, Inc.

• FDA approval · 2017-04-21
  FDA Approved: RENFLEXIS — Original Application (Organon LLC)

  The FDA approved RENFLEXIS (infliximab) from Organon LLC based on an original application, making it a biosimilar to Remicade. The approval …

• FDA approval · 2017-03-07
  FDA Approved: METHOTREXATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for METHOTREXATE SODIUM from Fresenius Kabi USA, LLC.

• FDA approval · 2017-01-11
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  The FDA approved a supplemental application for OTREXUP (methotrexate) filed by Antares Pharma, Inc. This update expands the regulatory auth…

• FDA approval · 2016-12-20
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  FDA approved a supplemental application for TREXALL (methotrexate) from Teva Women's Health, Inc.

• FDA approval · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• FDA approval · 2016-04-05
  FDA Approved: INFLECTRA — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved INFLECTRA (infliximab-dyyb) as a biosimilar to infliximab for multiple autoimmune diseases, expanding access to a biologic ther…

• FDA approval · 2016-02-29
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental application for Leflunomide by Apotex Corp., approving this generic product.

• FDA approval · 2016-02-22
  FDA Approved: SIMPONI ARIA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for Simponi Aria (golimumab) from Janssen Biotech, Inc., under BLA125433, to update the product …