Colgate Peroxyl wound-healing claim would require an NDA, FDA says.
This article was originally published in The Rose Sheet
COLGATE PEROXYL WOUND-HEALING CLAIM WOULD REQUIRE NDA APPROVAL, FDA told the company in a July 27 letter reviewing the protocol of a safety and efficacy study on the 1.5% hydrogen peroxide mouthrinse. Colgate-Palmolive, however, already has conducted the study and submitted the results to FDA on June 9 in support of its request for monograph status ("The Rose Sheet" July 3, In Brief). The company provided FDA with the protocol in November ("The Rose Sheet" Dec. 19, 1994, In Brief).
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