Plaque Psoriasis

• FDA approval · 2019-07-23
  FDA Approved: HADLIMA — Original Application (Organon LLC)

  FDA approves Hadlima (adalimumab-bwwd) from Organon as a biosimilar to Humira under the original application BLA761059. It is indicated for …

• FDA approval · 2019-06-13
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  The FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2019-05-24
  FDA Approved: CALCIPOTRIENE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Calcipotriene by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2019-04-25
  FDA Approved: DUOBRII — Original Application (Bausch Health US, LLC)

  FDA approved Duobrí (halobetasol propionate and tazarotene) as a new fixed-dose topical combination for the treatment of plaque psoriasis in…

• FDA approval · 2019-04-23
  FDA Approved: SKYRIZI — Original Application (AbbVie Inc.)

  FDA approved SKYRIZI (risankizumab-rzaa) from AbbVie as the original approval for adults with moderate to severe plaque psoriasis. Risankizu…

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• FDA approval · 2019-02-15
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's generic clobetasol propionate topical product under an Original Application (ANDA).

• FDA approval · 2019-02-13
  FDA Approved: FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% — Original Application (Encube Ethicals, Inc.)

  FDA approves Encube Ethicals' generic fluocinonide acetonide topical solution 0.01% (Original Application) for inflammatory and pruritic cor…

• FDA approval · 2018-12-21
  FDA Approved: CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental NDA for a generic calcipotriene and betamethasone dipropionate topical product from Prasco Laboratories.

• FDA approval · 2018-11-06
  FDA Approved: BRYHALI — Original Application (Bausch Health US, LLC)

  FDA approved Bryhali, the brand-name halobetasol propionate topical product, under an original NDA by Bausch Health US, LLC.

• FDA approval · 2018-11-05
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved the original application for Fluocinonide Acetonide (a generic topical corticosteroid) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2018-10-30
  FDA Approved: ADALIMUMAB — Original Application (Sandoz Inc)

  FDA approved the original application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc. The approval covers the same indication…

• FDA approval · 2018-10-23
  FDA Approved: DESOXIMETASONE — Original Application (The J. Molner Company LLC)

  FDA approved the original ANDA for desoximetasone, a topical corticosteroid, from The J. Molner Company LLC.

• FDA approval · 2018-10-16
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2018-10-09
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for SILIQ (brodalumab) filed by Bausch Health US LLC, updating the product's labeling to reflect…

• FDA approval · 2018-10-03
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation. The approval updates the labeling as descr…

• FDA approval · 2018-06-08
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2018-05-25
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation. The approval pertains to the supplement to…

• FDA approval · 2018-05-11
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for ENBREL (etanercept) submitted by Immunex Corporation. The action updates the drug's labeling…

• FDA approval · 2018-03-26
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a generic clobetasol propionate topical product from Glenmark Pharmaceuticals (ANDA 209004) for treatment of inflammatory and p…

• FDA approval · 2018-03-20
  FDA Approved: ILUMYA — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved ILUMYA (tildrakizumab-asmn) in an original application from Sun Pharmaceutical Industries. The approval covers its use for plaq…

• FDA approval · 2018-03-20
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2018-03-15
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2018-01-30
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic clobetasol propionate topical as an Original Application (ANDA). It is indicated for inflammator…

• FDA approval · 2018-01-26
  FDA Approved: SILIQ — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for SILIQ (brodalumab) submitted by Bausch Health US LLC.

• FDA approval · 2017-12-22
  FDA Approved: TAZAROTENE — Original Application (Mayne Pharma)

  FDA approved Mayne Pharma's original ANDA for tazarotene, enabling the generic topical retinoid product to enter the market.