US FDA Rides Different Monograph System In Second Roundup Of Oral Phenylephrine Efficacy
Executive Summary
“One of the things that we're particularly excited about under monograph reform is it does give us the opportunity to move things along a little bit more quickly,” says FDA Office of Nonprescription Drugs director Theresa Michele during NDAC meeting.
You may also be interested in...
US FDA Finds Phenylephrine Ineffective As Nasal Decongestant, Looks At Removing From Monograph
Phenylephrine doesn’t meet efficacy bar within “generally regarded as safe and effective” standard for OTC monograph drugs, agency says in briefing prepared for NDAC meeting on 11-12 September. FDA say it is “concerned about avoiding potential unintended consequences with regard to changing the GRASE status of oral PE.”
Asking Advisors About Phenylephrine Efficacy May Portend FDA Taking Streamlined Monograph Steps
NDAC will discuss whether data supports oral phenylephrine’s GRASE as nasal decongestant. Potential for removing phenylephrine from monograph could be linked to restricting nonprescription pseudoephedrine drugs to behind-the-counter sales since 2006 and overhaul of FDA monograph program authorized in 2020.
Petition Answers FDA Questions On Oral Phenylephrine Efficacy, Suggests Removal From Monograph
A citizen petition says studies have answered the question FDA and advisory committee members asked in 2007, for studies on the most effective dose of PE as a nasal decongestant. The studies show “PE is no more effective than placebo,” the petition says.