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Phenylephrine bitartrate

This article was originally published in The Tan Sheet

Executive Summary

Bayer will submit a citizen petition requesting that FDA reopen the cough/cold nasal decongestants monograph to include PEB, firm says. Company is looking to use the ingredient in Alka-Seltzer Plus effervescent formulations. During a Feb. 15 "feedback" meeting, FDA representatives suggested Bayer either submit a petition to reopen the monograph or file Section 505(b)(2) NDAs for each formulation (1"The Tan Sheet" Feb. 18, 2002, p. 4)...

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