Silver Diamine Fluoride Receives New FDA Designation

newslines_caries_featured

RUSN/ISTOCK/ THINKSTOCK

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.

One Response

  1. sarah mcmonigle December 30, 2016 Reply

Add a Comment

Your email address will not be published. Required fields are marked *

ADA Foundation Awards $120,000 in Funding to Eight Organizations 

 The ADA Foundation has awarded a total of $120,000 in funding...

A child smiling
CDC Cautions That Kids Are Using Too Much Toothpaste

Almost 40% or children between the ages of 3 and 6...

Jordan Baugh Joins American Dental Association

The American Dental Association (ADA) has named Jordan Baugh as its...

Study Examines Oral Health and Frailty

Researchers with the Department of Dentistry and Oral Surgery at Hyogo...

DentiMax
DentiMax Inc Complete Cloud Software Empowers Dentists

DentiMax Inc offers a complete, all-in-one, practice management and imaging cloud...

VIZ Intraoral Scanner
VIZ Intraoral Scanner from Adin Digital

The VIZ Intraoral Scanner from Adin Digital combines innovative imaging technologies,...

Sunset Dental Lab
Combination Partial from Sunset Dental Lab

Many patients who need a partial denture complain about the unsightly...

Etch e1
Etch e1 from eDentalProducts.com

The product, e1, manufactured by eDentalProducts.com is a 37% phosphoric acid etching...