Psoriatic Arthritis

• FDA approval · 2015-12-21
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for OTEZLA (apremilast) from Amgen that updated its labeling.

• FDA approval · 2015-11-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) filed by Cordavis Limited, indicating regulatory action on a Humira supp…

• FDA approval · 2015-06-19
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc. The approval updates the …

• FDA approval · 2015-03-25
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for ENBREL (etanercept), expanding its label with additional indications. The submission status indi…

• FDA approval · 2015-01-21
  FDA Approved: COSENTYX — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved the original Biologics License Application for Cosentyx (secukinumab) from Novartis Pharmaceuticals Corporation, establishing i…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2014-12-19
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2014-10-08
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  FDA approved a supplemental application for OTREXUP (methotrexate) submitted by Antares Pharma, Inc.

• FDA approval · 2014-09-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved Humira's supplemental application submitted by Cordavis Limited. The approval acts as a supplemental approval to the existing H…

• FDA approval · 2014-09-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) to add Cordavis Limited as a supplier. This action supports continued av…

• FDA approval · 2014-09-19
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for OTEZLA (apremilast) submitted by Amgen.

• FDA approval · 2014-07-28
  FDA Approved: OTEZLA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for OTEZLA (apremilast) from Amgen, potentially expanding or updating its label.

• FDA approval · 2014-05-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited under BLA125057.

• FDA approval · 2014-03-21
  FDA Approved: OTEZLA — Original Application (Amgen, Inc)

  FDA approved OTEZLA (apremilast) from Amgen in its Original Application for the treatment of plaque psoriasis and psoriatic arthritis.

• FDA approval · 2014-03-04
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab from Janssen Biotech, Inc., leading to changes in its labeling/approved use.

• FDA approval · 2014-01-16
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for cyclosporine from Apotex Corp, authorizing changes under the generic product's regulatory fi…

• FDA approval · 2013-10-11
  FDA Approved: OTREXUP — Original Application (Antares Pharma, Inc.)

  FDA approved OTREXUP, a subcutaneous methotrexate injection from Antares Pharma, under an original NDA for autoimmune conditions including r…

• FDA approval · 2013-05-15
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for Simponi (golimumab) from Janssen Biotech, Inc., expanding the labeling for the product.

• FDA approval · 2013-04-29
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab from Janssen Biotech, expanding its labeling and indications.

• FDA approval · 2013-04-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2013-02-05
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA's supplemental application for methotrexate, enabling the marketing of a generic methotrexate product…

• FDA approval · 2013-01-25
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc.

• FDA approval · 2012-12-10
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

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

• FDA approval · 2012-12-04
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

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

• FDA approval · 2012-09-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2012-05-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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