Psoriasis

• FDA approval · 2016-05-19
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' fluocinonide acetonide topical product through an original generic application (ANDA).

• FDA approval · 2016-05-19
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' fluocinonide acetonide topical product as an original application (ANDA 202368). The generic top…

• FDA approval · 2016-05-10
  FDA Approved: DESOXIMETASONE — Original Application (Novel Laboratories, Inc.)

  FDA approves a generic topical desoximetasone from Novel Laboratories, Inc. under an Original Application (ANDA 206792).

• FDA approval · 2016-02-05
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  The FDA approved a supplemental application for TACLONEX (calcipotriene and betamethone dipropionate) from LEO Pharma Inc., resulting in upd…

• FDA approval · 2015-12-23
  FDA Approved: ACITRETIN — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's generic acitretin for oral use under Original Application (ANDA 202552).

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• FDA approval · 2015-11-23
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved Lupin Pharmaceuticals' generic clobetasol propionate topical product under an Original Application (ANDA 206075).

• FDA approval · 2015-10-16
  FDA Approved: ENSTILAR — Original Application (LEO Pharma Inc.)

  FDA approved ENSTILAR, a fixed-dose topical combination of calcipotriene and betamethasone dipropionate for psoriasis.

• FDA approval · 2015-10-06
  FDA Approved: ACITRETIN — Supplemental Application (Sigmapharm Laboratories, LLC)

  The FDA approved a supplemental application for Acitretin from Sigmapharm Laboratories, LLC. The approval updates the regulatory status of A…

• FDA approval · 2015-09-10
  FDA Approved: ACITRETIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves an Original Application for ACITRETIN (acitretin) from Mylan Pharmaceuticals Inc., a generic for the treatment of psoriasis and…

• FDA approval · 2015-09-02
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Lupin Pharmaceuticals,Inc.)

  FDA approved the original application for a generic fluocinonide acetonide topical product by Lupin Pharmaceuticals (ANDA 206422).

• FDA approval · 2015-07-20
  FDA Approved: ACITRETIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for ACITRETIN (acitretin) from Teva Pharmaceuticals USA, Inc. under ANDA 202897.

• FDA approval · 2015-05-22
  FDA Approved: ACITRETIN — Original Application (Sigmapharm Laboratories, LLC)

  FDA approves the original application for acitretin (generic) from Sigmapharm Laboratories, LLC.

• FDA approval · 2015-04-20
  FDA Approved: DESOXIMETASONE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application for desoximetasone from Padagis Israel Pharmaceuticals Ltd, granting approval for a topical corticoste…

• FDA approval · 2015-03-11
  FDA Approved: CALCIPOTRIENE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for CALCIPOTRIENE from Prasco Laboratories. This action supplements the original NDA020554 for t…

• FDA approval · 2015-01-20
  FDA Approved: BETAMETHASONE VALERATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Betamethasone valerate from E. Fougera & Co., a division of Fougera Pharmaceuticals, LLC. Th…

• FDA approval · 2014-07-18
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, updating or expanding its labeling.

• FDA approval · 2014-07-14
  FDA Approved: FLUOCINONIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's Original Application for fluocinonide, a topical corticosteroid, as a generic product. This marks regulatory cle…

• FDA approval · 2014-07-14
  FDA Approved: FLUOCINONIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved an original application for fluocinonide from Sun Pharmaceutical Industries, a topical corticosteroid. The product is indicated…

• FDA approval · 2014-07-03
  FDA Approved: CALCIPOTRIENE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2014-05-12
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA has approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, Inc.

• 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 · 2014-01-14
  FDA Approved: CALCIPOTRIENE — Supplemental Application (Prasco Laboratories)

  FDA records a supplemental application for calcipotriene submitted by Prasco Laboratories (NDA 020554). The submission status is AP (supplem…

• 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 · 2013-09-20
  FDA Approved: DESOXIMETASONE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's desoximetasone for topical use under an Original Application (ANDA), expanding available generic corticosteroid opti…

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

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