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Nasal Decongestant Final Rule Six-Month Stay Sought By P&G

This article was originally published in The Tan Sheet

Executive Summary

A six-month stay of the effective date of FDA's final rule switching the name of the OTC nasal decongestant ingredient l-desoxyephedrine to levmetamfetamine is requested by Procter & Gamble in a Sept. 7 petition.

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OTC nasal decongestant monograph amended to add levmetamfetamine.

OTC NASAL DECONGESTANT MONOGRAPH AMENDED TO ADD LEVMETAMFETAMINE, formerly known as l-desoxyephedrine, as a safe and effective OTC active ingredient, FDA announces in a final rule published in the July 30 Federal Register. L-desoxyephedrine was excluded from the August 1994 final monograph for nasal decongestant drug products because U.S. Pharmacopoeial standards did not exist for the ingredient. USP proposed a monograph for l-desoxyephedrine in the January/February 1997 Pharmacopeial Forum, which included the name change to levmetamfetamine. In affirming levmetamfetamine's GRAS/E (generally recognized as safe/effective) status, the final rule removes l-desoxyephedrine from the list of nonmonograph active ingredients.

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