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Consumer OTC Drugs

Petition withdrawn

This article was originally published in The Tan Sheet

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Executive Summary

Unitel Technologies is withdrawing a citizen petition requesting OTC status for an Rx dose of dyclonine hydrochloride. The oral topical anesthetic was marketed by AstraZeneca until 2000 at 1% and .5% strengths; it is available as an OTC at lower doses. Unitel was seeking Category I safety and efficacy designation in the TFM for oral health care drug products for OTC human use, and would market the drug to dental health professionals. FDA recommended the petition be withdrawn; the Mount Prospect, Ill.-based firm is planning on submitting a switch application instead...

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