Hansen Disease

• 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…

• 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 · 2021-09-13
  FDA Approved: RIFAMPIN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Rifampin (RIFAMPIN) submitted by Chartwell RX, LLC under ANDA065390.

• CLINICAL_TRIALS withdrawal · 2017-04-05
  Clinical Trial Update: Virgin Coconut Oil Oral Supplementation for Leprosy Patients [Phase 1, Phase 2]

  A phase 1/phase 2 clinical trial evaluating virgin coconut oil as an oral supplement for Hansen's disease has been withdrawn.

• 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.

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• 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…