Silver Diamine Fluoride Receives New FDA Designation



The U.S. Food and Drug Administration (FDA) has granted its breakthrough therapy designation to silver diamine fluoride 38% (Advantage Arrest, Elevate Oral Care) for use in arresting dental caries in children and adults. Silver diamine fluoride was previously cleared by the FDA for treatment of dentinal hypersensitivity, although it has been used off-label for caries management.The breakthrough therapy designation represents the agency’s effort to expedite the development and review of drugs that are intended to treat a serious condition; it is granted when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies.

According to Elevate Oral Care, the special designation was granted based on FDA review of 10 worldwide randomized clinical trials evaluating silver diamine fluoride for caries arrest in children ages 3 to 9 and adults ages 60 to 89, as well as studies conducted by the manufacturer.

From Decisions in Dentistry. December 2016. 2(12):10.

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  1. sarah mcmonigle December 30, 2016 Reply

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