Plaque Psoriasis

• FDA approval · 2015-07-10
  FDA Approved: CALCIPOTRIENE — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for CALCIPOTRIENE submitted by Mayne Pharma.

• FDA approval · 2015-04-15
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for desoximetasone submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-04-13
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Triamcinolone Acetonide via an Original Application (ANDA) for Padagis Israel Pharmaceuticals Ltd., authorizing a generic corti…

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

  FDA approved a supplemental application for CALCIPOTRIENE (calcipotriene) by Prasco Laboratories.

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• 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 · 2015-02-18
  FDA Approved: MOMETASONE FUROATE — Supplemental Application (Encube Ethicals, Inc.)

  FDA approved a supplemental application for mometasone furoate from Encube Ethicals, Inc., granting approval of a supplemental ANDA for this…

• 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…

• FDA approval · 2014-12-23
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2014-12-12
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's original application for a calcipotriene and betamethasone dipropionate topical product, a…

• 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 · 2014-08-29
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  The FDA approved a supplemental application for Taclonex (calcipotriol and betamethasone dipropionate) from LEO Pharma Inc. The notice indic…

• FDA approval · 2014-07-28
  FDA Approved: TACLONEX — Supplemental Application (LEO Pharma Inc.)

  FDA approved a supplemental application for TACLONEX (calcipotriene and betamethasone dipropionate) from LEO Pharma Inc. The approval update…

• FDA approval · 2014-07-28
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approves Prasco Laboratories' supplemental application for calcipotriene and betamethasone dipropionate, a generic topical treatment for…

• 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 · 2014-06-19
  FDA Approved: DESOXIMETASONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Desoximetasone from Sun Pharmaceutical Industries, indicating approval of a supplemental for…

• FDA approval · 2014-06-12
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for calcipotriene and betamethasone dipropionate topical by Prasco Laboratories, authorizing a suppl…

• 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 · 2014-03-13
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the calcipotriene and betamethone dipropionate product submitted by Prasco Laboratories.

• 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 · 2013-12-13
  FDA Approved: TAZORAC — Supplemental Application (Almirall, LLC)

  The FDA approved a supplemental application for TAZORAC (tazarotene) filed by Almirall, LLC.