FDA Proposes “Sinusitis” Exclusion From OTC Nasal Decongestant Monograph
This article was originally published in The Tan Sheet
Executive Summary
FDA is seeking to amend the OTC nasal decongestant monograph by removing the indications that reference "sinusitis," the agency announced in a proposed rule slated for publication in the Aug. 2 Federal Register
You may also be interested in...
Sinusitis Indication Removed From OTC Decongestant Monograph
Marketers of OTC nasal decongestants have an April 11, 2007 deadline to remove references to the indication "sinusitis" from product labeling in order to comply with a monograph amendment
Sinusitis Exclusion From Nasal Decongestant Labels Is Unsupported – Pfizer
Physician intervention could be the only recourse for consumers suffering from sinusitis if FDA were to remove the indication from OTC product labels, according to Pfizer Consumer Healthcare
Nasal Decongestants Monograph Amendment On Sinusitis Claims Planned
FDA is targeting June for a proposed amendment to the cough/cold nasal decongestant monograph regarding sinusitis claims, according to the agency's recently published "unified agenda.