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
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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. Pepcid , Tagamet , Zantac and Axid all are examples of Rx heartburn medications that switched OTC with the names Pepcid AC , Pepcid Complete and Maximum Strength Pepcid AC , Tagamet HB 200 , Zantac 75 and Axid AR , respectively. FDA allowed the Rx names to be used, "even though almost every previous switch did not switch an Rx-strength product (unlike Prilosec OTC), and even though the Rx and OTC indications are different," the firm states. If FDA forces a name change, Prilosec OTC "would be the only branded OTC acid reducer not sold under a variant of the Rx product's trade name." Moreover, "it would be arbitrary for the agency to deny the use of the name Prilosec OTC," P&G asserts. "The use of the same trade name for acids or bases and their salts is common in both the Rx and OTC settings, and has been repeatedly approved by the agency," the letter states. For example, Advil and Advil Migraine use both the acid or base ibuprofen and the ibuprofen salt. Similarly, Children's Benadryl uses the salt diphenhydramine HCl and diphenhydramine citrate. Mylan Labs' submitted comments Oct. 29 in support of a citizen petition requesting FDA to force a name change for Prilosec OTC (omeprazole magnesium) (1 (Also see "Prilosec OTC Patent Extension Request “Compels” Name Change – Mylan" - Pink Sheet, 8 Nov, 2004.), p. 4). The petition originally was filed by law firm Mattingly, Stanger & Malur, who argued the name should be modified because consumers could be confused by the different indications for the OTC and Rx versions (2 (Also see "Prilosec OTC Name Will Create Consumer Confusion With Rx Drugs – Petition" - Pink Sheet, 18 Aug, 2003.), p. 3). In Mylan's most recent comments, the firm points to AstraZeneca's patent extension application as proof that omeprazole and omeprazole magnesium are different ingredients. The petition currently is under review by the U.S. Patent & Trademark Office (3 (Also see "Prilosec OTC Patent Extension Submission Pending At PTO" - Pink Sheet, 20 Sep, 2004.), p. 3). AstraZeneca's pursuit of a patent extension for Prilosec OTC is irrelevant to any debate over a change of the proton pump inhibitor's name, P&G maintains. "Whether an ingredient and its salt are legally the 'same' or 'different' depends purely on context," the petition states. "Active ingredients and salts are the same for purposes of determining the length of regulatory exclusivity for newly approved drugs," P&G continues. In other words, the active ingredients in this case "have no relevance to consumers, to therapeutic effect or to product names," P&G claims. P&G markets omeprazole magnesium rather than omeprazole in the OTC form because tablets are preferred by consumers, according to the firm. "The base ingredient in capsule form could have been more easily switched." "There is no question that omeprazole and omeprazole magnesium share the same...molecular form 'responsible for the...pharmacological action of the drug substance,'" the firm asserts. Members of FDA's Nonprescription Drugs and Gastrointestinal Drugs advisory committee did not question P&G's intention to use the name Prilosec OTC when considering the switch since bioavailability studies "indicate[d] their toxicokinetic and toxicological profile are equivalent," P&G points out. "The agency's consideration of the minor differences between the two formulations was also illustrated through the requirement of demonstrating safe, effective and correct consumer usage of Prilosec OTC tablets, bearing a 'Prilosec' name, in an OTC setting," the firm adds. "Significantly, massive consumer confusion would result from the forced renaming" of Prilosec OTC, P&G maintains. "No basis exists for forcing consumers to search out a renamed brand, or for forcing a product marketer to establish a new brand name over a year after a significant product launch," the firm concludes. |