Psoriatic Arthritis

• FDA approval · 2012-05-02
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., resulting in a labeling change/addition.

• FDA approval · 2012-04-17
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2011-12-26
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2011-12-13
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2011-09-07
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Cimzia (certolizumab pegol) submitted by UCB, Inc. This action approves the changes described in…

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• FDA approval · 2011-09-07
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2011-08-29
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Leflunomide (generic) submitted by Chartwell RX, LLC under an ANDA, enabling market authorizatio…

• FDA approval · 2011-08-18
  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.

• FDA approval · 2011-02-17
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., signaling a labeling update or expansion of its appro…

• FDA approval · 2010-12-28
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved Janssen Biotech, Inc.'s supplemental application for infliximab. The approval updates the product's labeling and indications as…

• FDA approval · 2010-07-29
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2010-07-29
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc., resulting in an approved amendment to it…

• FDA approval · 2010-06-03
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

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

• FDA approval · 2009-12-30
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2009-05-13
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2009-04-24
  FDA Approved: SIMPONI — Original Application (Janssen Biotech, Inc.)

  FDA approved the original Biologics License Application for Simponi (golimumab) from Janssen Biotech, Inc.

• FDA approval · 2008-04-07
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  The FDA approved a supplemental application for Orencia (abatacept) submitted by E.R. Squibb & Sons, L.L.C., resulting in an update to its l…

• FDA approval · 2007-07-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2007-06-12
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for infliximab (Remicade) submitted by Janssen Biotech, Inc. The approval updates the labeling to re…

• FDA approval · 2007-04-30
  FDA Approved: METHOTREXATE — Original Application (Accord Healthcare, Inc.)

  The FDA approved Accord Healthcare's original application for Methotrexate (generic).

• FDA approval · 2007-04-19
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab (Remicade) from Janssen Biotech, Inc., updating the product labeling per the supp…

• FDA approval · 2007-03-13
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) from E.R. Squibb & Sons, L.L.C.

• FDA approval · 2006-12-12
  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 an approved update to th…

• FDA approval · 2006-12-08
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2006-09-26
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., updating the drug's labeling.