Dermatitis Herpetiformis

• FDA approval · 2026-02-26
  FDA Approved: DAPSONE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved DAPSONE through an Original Application (ANDA) by Viona Pharmaceuticals Inc. The approval covers the generic use of DAPSONE for…

• CLINICAL_TRIALS other · 2025-09-17
  Clinical Trial Update: Background of Different Phenotypes of Coeliac Disease

  Clinical trial exploring different phenotypes of celiac disease and dermatitis herpetiformis; recruitment is ongoing.

• FDA approval · 2025-06-17
  FDA Approved: DAPSONE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for DAPSONE submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2025-04-23
  FDA Approved: DAPSONE — Supplemental Application (Seton Pharmaceuticals)

  FDA approved a supplemental application for DAPSONE tablets from Seton Pharmaceuticals.

• FDA approval · 2025-04-04
  FDA Approved: DAPSONE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's Original Abbreviated New Drug Application for DAPSONE (dapsone), a generic antibiotic used for d…

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• FDA approval · 2024-08-26
  FDA Approved: DAPSONE — Original Application (Trupharma, LLC)

  FDA approves a generic version of dapsone (DAPSONE) under Original Application by Trupharma, LLC (ANDA213636).

• FDA approval · 2024-05-08
  FDA Approved: DAPSONE — Original Application (Zydus Lifesciences Limited)

  FDA approves DAPSONE from Zydus Lifesciences Limited as an Original Application, providing a generic dapsone product.

• FDA approval · 2023-10-27
  FDA Approved: DAPSONE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved the original application for DAPSONE (dapsone) as a generic drug from Alembic Pharmaceuticals Inc.

• FDA approval · 2023-10-19
  FDA Approved: DAPSONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved the generic dapsone (DAPSONE) under Amneal Pharmaceuticals LLC's Original ANDA.

• FDA approval · 2023-05-31
  FDA Approved: DAPSONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the Original Application for Dapsone (DAPSONE) by Amneal Pharmaceuticals NY LLC, authorizing a generic version of the drug.

• FDA approval · 2022-02-10
  FDA Approved: DAPSONE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the original application for DAPSONE (dapsone) as a generic drug manufactured by Torrent Pharmaceuticals Limited.

• FDA approval · 2022-02-04
  FDA Approved: DAPSONE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved an original application for DAPSONE from Mylan Pharmaceuticals, granting generic market authorization.

• FDA approval · 2019-05-08
  FDA Approved: DAPSONE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approves the Original Application for DAPSONE from Rising Pharma Holdings, Inc., enabling a generic version of the drug.

• CLINICAL_TRIALS trial_result · 2018-03-06
  Clinical Trial Update: Study of Enzyme Supplements to Treat Celiac Disease [Phase 1, Phase 2]

  A Phase 1/2 clinical trial evaluating enzyme supplements for treating celiac disease (also affecting dermatitis herpetiformis) has completed…

• CLINICAL_TRIALS trial_result · 2017-12-14
  Clinical Trial Update: Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis [Phase 4]

  Phase 4 trial of dapsone gel 5% for dermatitis herpetiformis was terminated; results posted in 2017. No further details provided here.

• FDA approval · 2017-10-16
  FDA Approved: DAPSONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic version of dapsone (DAPSONE) through an original ANDA. The approval authorizes the sale …

• FDA approval · 2016-12-01
  FDA Approved: DAPSONE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' generic DAPSONE (dapsone) under an Original Application (ANDA206505).

• CLINICAL_TRIALS research · 2016-09-27
  Clinical Trial Update: Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases

  Observational study by the University of Zurich investigating the genetic architecture of neutrophil-mediated inflammatory skin diseases, li…

• FDA approval · 2016-05-10
  FDA Approved: DAPSONE — Original Application (Chartwell RX, LLC)

  The FDA approved the original ANDA for DAPSONE from Chartwell RX, LLC.

• FDA approval · 2015-07-09
  FDA Approved: DAPSONE — Supplemental Application (Pacific Pharma, Inc.)

  The FDA approved a supplemental application for DAPSONE submitted by Pacific Pharma, Inc.

• FDA approval · 2013-10-03
  FDA Approved: DAPSONE — Supplemental Application (Pacific Pharma, Inc.)

  The FDA approved a supplemental application for Dapsone from Pacific Pharma, Inc., resulting in changes to the product labeling under the su…