Sinusitis Indication Removed From OTC Decongestant Monograph
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
Replacing Pseudoephedrine Easier Said Than Done, OTC Firms Find
Reformulating pseudoephedrine products has posed a greater challenge than expected for a number of firms, as passage of a federal bill restricting sale of the ingredient looms
Perrigo’s Full Range Of Pseudoephedrine Stand-Ins Must Wait For Next Year
Perrigo will not have a complete phenylephrine portfolio available to replace pseudoephedrine products until next year's cough/cold season, the company said during a fiscal 2006 first-quarter earnings call
FDA Proposes “Sinusitis” Exclusion From OTC Nasal Decongestant Monograph
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