Atopic Dermatitis

• FDA approval · 2021-11-04
  FDA Approved: HYDROCORTISONE VALERATE CREAM — Original Application (Encube Ethicals, Inc.)

  FDA approved Hydrocortisone Valerate Cream by Encube Ethicals as an Original Application; a generic topical corticosteroid indicated for inf…

• FDA approval · 2021-09-21
  FDA Approved: OPZELURA — Original Application (Incyte Corporation)

  FDA approved OPZELURA (ruxolitinib) cream as the original approval for the topical treatment of atopic dermatitis.

• FDA approval · 2021-04-02
  FDA Approved: FLUOCINOLONE ACETONIDE — Original Application (Quagen Pharmaceuticals LLC)

  FDA approved the Original Application for fluocinonide acetonide topical product. The generic is manufactured by Quagen Pharmaceuticals LLC.

• FDA approval · 2021-02-11
  FDA Approved: HYDROCORTISONE VALERATE — Original Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' original application for hydrocortisone valerate, a generic topical corticosteroid for inflammator…

• FDA approval · 2021-02-05
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approves a generic Triamcinolone Acetonide topical product under an Original Application (ANDA) for Padagis Israel Pharmaceuticals Ltd.

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• EMA approval · 2020-09-18
  New oral treatment for moderate to severe atopic dermatitis

  The EMA announces a new oral treatment for adults with moderate to severe atopic dermatitis, representing a new therapeutic option for this …

• FDA approval · 2020-08-28
  FDA Approved: CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% — Original Application (Northstar Rx LLC)

  FDA approved Northstar Rx LLC's generic clobetasol propionate cream 0.05% (ANDA212982), a potent topical corticosteroid indicated for inflam…

• FDA approval · 2020-08-27
  FDA Approved: HALOBETASOL PROPIONATE — Supplemental Application (Coral Way Pharma, LLC)

  FDA approved a supplemental application for halobetasol propionate filed by Coral Way Pharma, LLC.

• FDA approval · 2020-08-24
  FDA Approved: DESONIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' desonide product under an Original Application, making a generic desonide topical product available. D…

• FDA approval · 2020-07-14
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved the original application for Betamethasone Dipropionate by Viona Pharmaceuticals Inc, granting it as a generic topical corticos…

• FDA approval · 2020-07-07
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The U.S. FDA approved a supplemental application for betamethasone dipropionate from Glenmark Pharmaceuticals Inc., USA. This action adds re…

• FDA approval · 2020-06-17
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original application for Betamethasone Dipropionate topical, a potent corticosteroid for inflammatory …

• FDA approval · 2020-06-15
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Betamethasone Dipropionate from E. Fougera & Co., indicating an approval related to the gene…

• FDA approval · 2020-06-09
  FDA Approved: BETAMETHASONE DIPROPIONATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Betamethasone Dipropionate by Actavis Pharma, Inc., indicating an update to the product's approv…

• FDA approval · 2020-06-01
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's Triamcinolone acetonide via an Original Application (ANDA) for a generic formulation.

• FDA approval · 2020-03-23
  FDA Approved: EUCRISA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for EUCRISA (crisaborole) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2020-03-04
  FDA Approved: HYDROCORTISONE VALERATE — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approved the original application for hydrocortisone valerate by Cosette Pharmaceuticals, Inc., establishing a new generic topical corti…

• FDA approval · 2020-02-10
  FDA Approved: FLUOCINONIDE — Original Application (Zydus Lifesciences Limited)

  The FDA approved the original application for a generic fluocinolone topical product from Zydus Lifesciences Limited. The approval confirms …

• FDA approval · 2020-01-27
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's generic clobetasol propionate topical product under an original application, expanding access…

• FDA approval · 2019-12-30
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved an original application for clobetasol propionate topical from Torrent Pharmaceuticals Limited (generic).

• FDA approval · 2019-12-18
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved an original application for Betamethasone dipropionate by Lupin Pharmaceuticals, Inc., granting a generic topical corticosteroi…

• FDA approval · 2019-11-29
  FDA Approved: TRIAMCINOLONE ACETONIDE — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals' Triamcinolone Acetonide Ointment USP, 0.05% as an original generic topical corticosteroid product through …

• FDA approval · 2019-11-26
  FDA Approved: FLUOCINONIDE — Original Application (Xiromed LLC)

  FDA approved the original application for fluocinonide (topical corticosteroid) submitted by Xiromed LLC.

• FDA approval · 2019-11-15
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Encube Ethicals, Inc.)

  FDA approved the Original Application for Clobetasol Propionate Ointment USP, 0.05% (generic) by Encube Ethicals, Inc.

• FDA approval · 2019-10-23
  FDA Approved: DESONIDE — Original Application (Alembic Pharmaceuticals Inc.)

  The FDA approved an original ANDA for desonide from Alembic Pharmaceuticals Inc., enabling the sale of generic desonide products.