Psoriasis

• FDA approval · 2013-08-09
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic topical fluocinonide acetonide product under an original application from Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2013-04-04
  FDA Approved: ACITRETIN — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved the original application for Acitretin (generic) from Teva Pharmaceuticals USA, Inc., for the treatment of psoriasis.

• FDA approval · 2013-04-04
  FDA Approved: ACITRETIN — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic acitretin (ACITRETIN) under an Original Application. This confirms the approval status for Teva's generic acitre…

• FDA approval · 2013-03-20
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for desoximetasone from Sun Pharmaceutical Industries, Inc., resulting in an updated approval for th…

• 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…

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• FDA approval · 2012-11-30
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Calcipotriene and Betamethone Dipropionate submitted by Prasco Laboratories. It pertains to the …

• FDA approval · 2012-11-26
  FDA Approved: BETAMETHASONE VALERATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a generic topical betamethasone valerate product from Padagis Israel Pharmaceuticals Ltd (Original Application).

• FDA approval · 2012-08-17
  FDA Approved: CLOBEX — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for CLOBEX (clobetasol propionate) submitted by Galderma Laboratories to update its labeling.

• FDA approval · 2012-08-09
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application for clobetasol propionate topical product (a generic) from Padagis Israel Pharmaceuticals Ltd under AN…

• FDA approval · 2012-06-28
  FDA Approved: MICORT HC CREAM — Supplemental Application (Legacy Pharma USA Inc.)

  FDA approved a supplemental application for MICORT HC CREAM (hydrocortisone acetate cream) from Legacy Pharma USA Inc., representing an appr…

• FDA approval · 2012-01-05
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Desoximetasone (Sun Pharmaceutical Industries, Inc.). The approval updates the product's lab…

• FDA approval · 2012-01-03
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, Inc., resulting in changes to the product lab…

• FDA approval · 2011-04-25
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for METHOTREXATE from Hikma Pharmaceuticals USA Inc., granting a supplemental approval for the g…

• FDA approval · 2011-03-24
  FDA Approved: CALCIPOTRIENE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved CALCIPOTRIENE from Cosette Pharmaceuticals, Inc. through an Original Application (ANDA). This is a generic drug approval.

• FDA approval · 2010-10-06
  FDA Approved: CALCIPOTRIENE — Original Application (Mayne Pharma)

  FDA approved the original application for CALCIPOTRIENE from Mayne Pharma. It is a topical vitamin D analog indicated for plaque psoriasis.

• FDA approval · 2009-10-08
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2009-09-24
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation, authorizing changes to the …

• FDA approval · 2009-05-26
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Betamethasone Dipropionate from Sun Pharmaceutical Industries, granting approval of a generi…

• FDA approval · 2009-01-23
  FDA Approved: VECTICAL — Original Application (Galderma Laboratories, L.P.)

  FDA granted original approval for VECTICAL (calcitriol) as a topical treatment for plaque psoriasis, marking the original application approv…

• FDA approval · 2008-09-23
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's original ANDA for topical betamethasone dipropionate, a generic corticosteroid, for inflammatory skin conditions…

• FDA approval · 2008-03-10
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an original application for a generic clobetasol propionate topical product by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2007-12-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for cyclosporine from Apotex Corp. This action approves additional labeling or supply under the supp…

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

  The FDA approved a supplemental application for CALCIPOTRIENE by Prasco Laboratories.

• FDA approval · 2007-08-01
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for NEORAL (cyclosporine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2007-05-21
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  FDA approved the original application for Betamethasone Dipropionate (a generic topical corticosteroid) from E. Fougera & Co., marking appro…