Atopic Dermatitis

• FDA approval · 2019-10-21
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' original ANDA for clobetasol propionate topical.

• FDA approval · 2019-10-08
  FDA Approved: OLUMIANT — Supplemental Application (Eli Lilly and Company)

  FDA approves Eli Lilly's supplemental application for OLUMIANT (baricitinib). This action updates the labeling to reflect expanded indicatio…

• FDA approval · 2019-10-02
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Micro Labs Limited)

  The FDA approved Micro Labs Limited's original application for clobetasol propionate topical, a potent corticosteroid, for inflammatory and …

• FDA approval · 2019-10-02
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for clobetasol propionate topical, a high-potency corticosteroid, enabli…

• FDA approval · 2019-09-24
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Zydus Lifesciences Limited)

  FDA approves the original application for clobetasol propionate topical (generic) by Zydus Lifesciences Limited, adding another generic opti…

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• FDA approval · 2019-09-17
  FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for tacrolimus from Sandoz Inc., resulting in changes to the approved product, such as labeling …

• FDA approval · 2019-09-06
  FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for clobetasol propionate from Sun Pharmaceutical Industries under an ANDA.

• FDA approval · 2019-09-06
  FDA Approved: CLOBETASOL PROPIONATE EMOLLIENT FORMULATION — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for a clobetasol propionate emollient formulation from Padagis Israel Pharmaceuticals Ltd, granting …

• FDA approval · 2019-09-06
  FDA Approved: CLOBETASOL PROPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for clobetasol propionate from Sun Pharmaceutical Industries, enhancing its approval under the gener…

• FDA approval · 2019-08-29
  FDA Approved: PIMECROLIMUS — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for PIMECROLIMUS from Glenmark Pharmaceuticals Inc., USA for topical use in atopic dermatitis.

• 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 · 2019-01-30
  FDA Approved: DESONIDE OINTMENT, 0.05% — Original Application (Encube Ethicals, Inc.)

  FDA approved Desonide Ointment 0.05% as a generic topical corticosteroid for relief of inflammatory and pruritic skin conditions; indicated …

• FDA approval · 2018-12-27
  FDA Approved: PIMECROLIMUS — Original Application (Actavis Pharma, Inc.)

  FDA approves Actavis Pharma, Inc.'s original application for a generic pimecrolimus topical product. The product is indicated for the treatm…

• FDA approval · 2018-12-26
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (AvKARE)

  FDA approved AvKARE's original ANDA for clobetasol propionate topical product (generic).

• FDA approval · 2018-12-14
  FDA Approved: HYDROCORTISONE VALERATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's hydrocortisone valerate as a generic topical corticosteroid under an original ANDA (ANDA211750).

• FDA approval · 2018-11-29
  FDA Approved: FLUOCINONIDE — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals, Inc.'s fluocinonide topical solution 0.05% as a generic topical corticosteroid for inflammatory and prurit…

• 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 · 2018-10-23
  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 · 2018-10-19
  FDA Approved: DUPIXENT — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for DUPIXENT (dupilumab) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2018-10-16
  FDA Approved: FLUOCINONIDE — Original Application (Encube Ethicals, Inc.)

  FDA approved Fluocinonide under Encube Ethicals, Inc.'s Original Application (ANDA 211410), establishing regulatory approval for this topica…

• FDA approval · 2018-10-12
  FDA Approved: BETAMETHASONE DIPROPIONATE — Original Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' original application for a generic Betamethasone Dipropionate topical product.

• FDA approval · 2018-10-04
  FDA Approved: CLOBETASOL PROPIONATE — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved CLOBETASOL PROPIONATE as an original-application generic topical product. The approval holder is Taro Pharmaceuticals U.S.A., I…

• FDA approval · 2018-09-28
  FDA Approved: DESOXIMETASONE — Original Application (Viona Pharmaceuticals Inc)

  The FDA approved Viona Pharmaceuticals Inc.'s desoximetasone topical product as an original application, providing a generic version of the …

• FDA approval · 2018-08-21
  FDA Approved: FLUOCINONIDE CREAM — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic fluocinonide cream from Amneal Pharmaceuticals NY LLC (ANDA 210554).