Rosacea

• FDA approval · 2015-12-28
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for AZELAIC ACID GEL from Sandoz Inc.

• FDA approval · 2015-09-23
  FDA Approved: MIRVASO — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for Mirvaso (brimonidine tartrate) submitted by Galderma Laboratories, L.P., related to its labe…

• FDA approval · 2015-09-21
  FDA Approved: DOXYCYCLINE HYCLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Doxycycline Hyclate by Hikma Pharmaceuticals USA Inc., indicating a change to the product's labe…

• FDA approval · 2015-09-03
  FDA Approved: ORACEA — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for ORACEA (doxycycline) filed by Galderma Laboratories to update the product labeling.

• FDA approval · 2015-07-29
  FDA Approved: FINACEA FOAM — Original Application (LEO Pharma Inc.)

  FDA approved Finacea Foam, a topical azelaic acid product by LEO Pharma, under an original NDA. It is indicated for the treatment of rosacea…

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• FDA approval · 2015-06-14
  FDA Approved: METRONIDAZOLE — Supplemental Application (Encube Ethicals, Inc.)

  The FDA approved a supplemental application for Metronidazole topical from Encube Ethicals, Inc., resulting in updated labeling for the prod…

• FDA approval · 2015-04-03
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for azelaic acid gel from Sandoz Inc., updating the product’s regulatory status via a supplemental N…

• FDA approval · 2015-03-03
  FDA Approved: MIRVASO — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for Mirvaso (brimonidine tartrate) submitted by Galderma Laboratories, L.P. The action updates the e…

• FDA approval · 2015-02-03
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for AZELAIC ACID GEL submitted by Sandoz Inc., approving changes to its labeling.

• FDA approval · 2014-12-19
  FDA Approved: SOOLANTRA — Original Application (Galderma Laboratories, L.P.)

  FDA approved Soolantra (ivermectin) cream for the treatment of inflammatory lesions of rosacea. This original NDA approval introduces topica…

• FDA approval · 2014-10-23
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approves a supplemental application for AZELAIC ACID GEL (AZELAIC ACID) from Sandoz Inc.

• FDA approval · 2014-09-05
  FDA Approved: MIRVASO — Supplemental Application (Galderma Laboratories, L.P.)

  The FDA approved a supplemental application for Mirvaso (brimonidine tartrate) from Galderma Laboratories, L.P. This action represents an up…

• FDA approval · 2013-08-23
  FDA Approved: MIRVASO — Original Application (Galderma Laboratories, L.P.)

  FDA approved Mirvaso (brimonidine tartrate) gel via an original NDA from Galderma Laboratories for the treatment of facial erythema associat…

• FDA approval · 2013-07-25
  FDA Approved: ORACEA — Supplemental Application (Galderma Laboratories, L.P.)

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

• FDA approval · 2012-12-18
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approves a supplemental application for azelaic acid gel from Sandoz Inc.

• FDA approval · 2012-11-07
  FDA Approved: ORACEA — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental NDA for ORACEA (doxycycline 40 mg) by Galderma Laboratories, L.P.

• FDA approval · 2010-10-25
  FDA Approved: AZELAIC ACID GEL — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for AZELAIC ACID GEL from Sandoz Inc., indicating approval of a supplemental NDA related to this pro…

• FDA approval · 2010-05-13
  FDA Approved: ORACEA — Supplemental Application (Galderma Laboratories, L.P.)

  FDA approved a supplemental application for ORACEA (doxycycline) submitted by Galderma Laboratories, L.P., related to the product's labeling…

• FDA approval · 2007-10-25
  FDA Approved: METRONIDAZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for metronidazole (ANDA070027), authorizing changes to the approved product through a supplemen…

• FDA approval · 2007-06-27
  FDA Approved: METRONIDAZOLE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Metronidazole from Chartwell RX, LLC (ANDA number 076522).

• FDA approval · 2006-07-13
  FDA Approved: METRONIDAZOLE — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals, Inc.'s original application for topical metronidazole, making the generic topical product available.

• FDA approval · 2006-05-26
  FDA Approved: ORACEA — Original Application (Galderma Laboratories, L.P.)

  The FDA approved ORACEA (doxycycline) under an original NDA for the treatment of inflammatory lesions of rosacea in adults. It uses a 40 mg …