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)...
You may also be interested in...
Phenylephrine Bitartrate Foreign Marketing Data Requested By FDA
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
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.