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FDA Approved Drug Rosacea Treatments

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Not all rosacea treatments are FDA approved. The process to have a drug approved to treat rosacea has many hoops to jump through and the cost is not for the faint of heart. FDA approval of a drug means that data on the drug’s effects have been reviewed by FDA's Center for Drug Evaluation and Research (CDER), and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. [1] There are a number of drug treatments not FDA approved for rosacea that are being used for this purpose and this is called 'off label' drug treatment. [2] We are listing here only the rosacea drug treatments that are approved by the FDA in alphabetical order. We will continue to add to this page FDA approved drug rosacea treatments. 

Azelaic Acid (topical, Finacea) [3]

Brimonidine (topical, Mirvaso)

Ivermectin (topical, Soolantra)

Metronidazole (topical) [3]

Oxymetazoline Hydrochloride (topical, Rhofade)

Sulfacetamide/Sulphur (topical) 

Tetracycline (oral) [3]

        Doxycycline (oral, Oracea) [3]

        Minocycline (oral, topical, Zilxi) [3]

End Notes 

[1] Development & Approval Process | Drugs, FDA

[2] Understanding Unapproved Use of Approved Drugs "Off Label", FDA

[3] "Standard treatments approved by the FDA include azelaic acid, topical metronidazole, and oral tetracyclines, in particular minocycline and doxycycline."
P T. 2009 Jan; 34(1): 38–45.
Rosacea: A Review
Brittney Culp, BA and Noah Scheinfeld, MD

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