Plaque Psoriasis

• 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 · 2009-09-25
  FDA Approved: USTEKINUMAB — Original Application (Janssen Biotech, Inc.)

  The FDA approved ustekinumab (Stelara) from Janssen Biotech as the original approval for adults with moderate to severe plaque psoriasis.

• FDA approval · 2009-03-20
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  The FDA approved a supplemental application for Taclonex (calcipotriene and betamethasone dipropionate) from LEO Pharma Inc., updating its l…

• FDA approval · 2008-05-09
  FDA Approved: TACLONEX — Original Application (LEO Pharma Inc.)

  FDA approved Taclonex, a topical combination of calcipotriol and betamethasone dipropionate, under Original Application by LEO Pharma Inc. f…

• FDA approval · 2007-09-26
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Calcipotriene and Betamethone Dipropionate from Prasco Laboratories, updating labeling/indicatio…

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• FDA approval · 2007-09-26
  FDA Approved: CALCIPOTRIENE — Supplemental Application (Prasco Laboratories)

  The FDA approves a supplemental application for Calcipotriene submitted by Prasco Laboratories.

• 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 · 2007-05-21
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a generic topical corticosteroid, Betamethasone Dipropionate, under Sun Pharmaceutical Industries' Original Application.

• FDA approval · 2007-04-24
  FDA Approved: HALOBETASOL PROPIONATE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' original application for halobetasol propionate, a potent topical corticosteroid used to treat inflamm…

• 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 · 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.

• FDA approval · 2006-09-15
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Calcipotriene and Betamethasone Dipropionate submitted by Prasco Laboratories.

• FDA approval · 2006-07-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited, likely to authorize a new contract manufactur…

• FDA approval · 2006-06-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to market a generic cyclosporine product.

• FDA approval · 2006-05-08
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for cyclosporine (Apotex Corp.) under an ANDA, indicating approval of a supplemental update to this …