OTC Prilosec Name Derivative Has Precedent In Other Rx Heartburn Switches
This article was originally published in The Tan Sheet
Executive Summary
FDA has set multiple precedents of switching Rx heartburn remedies over-the-counter while permitting the same trade name for both versions, and should not force a name change for Prilosec OTC, Procter & Gamble says in recent comments to FDA
You may also be interested in...
Prilosec OTC Patent Extension Request “Compels” Name Change – Mylan
AstraZeneca's efforts to extend a patent for Prilosec OTC bolster the case for mandating a name change for the nonprescription product, Mylan says in Oct. 29 comments to FDA
Prilosec OTC Patent Extension Submission Pending At PTO
AstraZeneca appears to be building its case to ward off eventual private label competition for Prilosec OTC upon expiration of Hatch/Waxman exclusivity
Prilosec OTC Name Will Create Consumer Confusion With Rx Drugs – Petition
FDA should require that Prilosec OTC be sold under a different brand name to "reduce the risk of consumer confusion" resulting from extensive direct-to-consumer advertising for the Rx version of the drug, an Aug. 12 citizen petition says