Rosacea

• FDA approval · 2025-04-02
  FDA Approved: ORACEA — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approves a supplemental application for ORACEA (doxycycline) from Galderma Laboratories, L.P.

• EMA approval · 2025-03-04
  EMA Authorised: Mirvaso (brimonidine tartrate) — Galderma International

  The European Medicines Agency authorised Mirvaso (brimonidine tartrate) for rosacea-related facial erythema. The marketing authorization hol…

• FDA approval · 2025-02-14
  FDA Approved: METRONIDAZOLE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for metronidazole from Alembic Pharmaceuticals Limited.

• FDA approval · 2024-12-17
  FDA Approved: METRONIDAZOLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Metronidazole from Sun Pharmaceutical Industries, Inc., resulting in continued approval of this …

• FDA approval · 2024-10-25
  FDA Approved: METRONIDAZOLE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metronidazole filed by Aurobindo Pharma Limited, authorizing the generic product under the suppl…

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• FDA approval · 2024-06-18
  FDA Approved: METRONIDAZOLE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for metronidazole from Heritage Pharmaceuticals Inc. (d/b/a Avet Pharmaceuticals Inc.) to modify…

• FDA approval · 2024-03-14
  FDA Approved: DOXYCYCLINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for doxycycline, a generic antibiotic, expanding the availability of doxycycline pr…

• FDA approval · 2024-03-06
  FDA Approved: AZELAIC ACID — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for azelaic acid by Actavis Pharma, expanding/updating its labeling.

• FDA approval · 2024-02-20
  FDA Approved: AZELEX — Supplemental Application (Almirall, LLC)

  FDA supplemental application for AZELEX (azelaic acid) submitted by Almirall, LLC.

• FDA approval · 2022-10-31
  FDA Approved: AZELAIC ACID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for azelaic acid from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2022-10-14
  FDA Approved: SOOLANTRA — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for Soolantra (ivermectin) submitted by Galderma Laboratories, L.P., resulting in an approved supple…

• FDA approval · 2022-07-01
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Encube Ethicals, Inc.)

  FDA approved a supplemental application for AZELAIC ACID GEL from Encube Ethicals, Inc. under ANDA208724.

• FDA approval · 2022-04-22
  FDA Approved: EPSOLAY — Original Application (Galderma Laboratories, L.P.)

  FDA approved EPSOLAY (benzoyl peroxide) through an Original Application by Galderma Laboratories, L.P. for the treatment of inflammatory les…

• FDA approval · 2021-12-15
  FDA Approved: ORACEA — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for ORACEA (doxycycline) from Galderma Laboratories, L.P.

• FDA approval · 2020-12-01
  FDA Approved: FINACEA FOAM — Supplemental Application (LEO Pharma Inc.)

  FDA approved a supplemental application to add FINACEA FOAM, a topical azelaic acid product from LEO Pharma, for the treatment of Rosacea.

• FDA approval · 2020-11-27
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for azelaic acid gel from Sandoz Inc., indicating continued approval and potential label updates.

• FDA approval · 2020-05-28
  FDA Approved: ZILXI — Original Application (Journey Medical Corporation)

  FDA approved ZILXI (minocycline) from Journey Medical Corporation via an original NDA for the treatment of inflammatory lesions of rosacea.

• FDA approval · 2019-10-18
  FDA Approved: AMZEEQ — Original Application (Journey Medical Corporation)

  FDA approved AMZEEQ (minocycline) from Journey Medical Corporation under an Original Application for the treatment of inflammatory lesions o…

• FDA approval · 2018-11-19
  FDA Approved: AZELAIC ACID — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's azelaic acid product under an Original Application (ANDA 204637).

• FDA approval · 2018-11-19
  FDA Approved: AZELAIC ACID GEL — Original Application (Encube Ethicals, Inc.)

  FDA approved an original application for AZELAIC ACID GEL by Encube Ethicals, Inc., enabling marketing of a generic azelaic acid gel in the …

• FDA approval · 2018-11-19
  FDA Approved: AZELAIC ACID — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's azelaic acid product under an Original Application (ANDA), providing a generic option for azelaic acid topical…

• FDA approval · 2018-04-19
  FDA Approved: SOOLANTRA — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for Soolantra (ivermectin) from Galderma Laboratories, L.P. This action updates the product labeling…

• FDA approval · 2017-01-18
  FDA Approved: RHOFADE — Original Application (EPI Health, LLC)

  FDA approves Rhofade (oxymetazoline hydrochloride) from EPI Health as an original application for the treatment of persistent facial redness…

• FDA approval · 2016-11-16
  FDA Approved: METRONIDAZOLE — Original Application (Viona Pharmaceuticals Inc)

  FDA approved Metronidazole via an original application from Viona Pharmaceuticals Inc (ANDA206560). The approval confirms its use for anaero…

• FDA approval · 2016-07-27
  FDA Approved: MIRVASO — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for MIRVASO (brimonidine tartrate) submitted by Galderma Laboratories, L.P.