Phenylephrine Bitartrate Foreign Marketing Data Requested By FDA
This article was originally published in The Tan Sheet
Executive Summary
Bayer should supply foreign marketing data for phenylephrine bitartrate (PEB) to support its request the ingredient be approved for use as a nasal decongestant, FDA said at a "feedback" meeting in Rockville, Md. Feb. 15
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FDA is proposing to amend the over-the-counter nasal decongestant drugs monograph to include phenylephrine bitartrate (PEB) in effervescent tablets, according to an announcement published in the Federal Register Nov. 2
Bayer Bubbles Over Proposed Cough/Cold Monograph Amendment
FDA is proposing to amend the over-the-counter nasal decongestant drugs monograph to include phenylephrine bitartrate (PEB) in effervescent tablets, according to an announcement published in the Federal Register Nov. 2