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S-P files NDA for OTC Zegerid

This article was originally published in The Tan Sheet

Executive Summary

Schering-Plough has filed an Rx-to-OTC switch application with FDA for its proton-pump inhibitor/antacid combination Zegerid (20 mg omeprazole/1100 mg sodium bicarbonate) to treat frequent heartburn, according to a March 11 release. The new drug application was filed under the terms of an October 2006 licensing agreement with San Diego-based Santarus, which discussed the product during a March 3 earnings call (1"The Tan Sheet" March 10, 2008, p. 4). Under standard FDA review, the product could be approved and on the market in early 2009. The immediate-release formula could provide an advantage in the market against Procter & Gamble's OTC PPI Prilosec OTC and private label equivalents...

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Zegerid on track

Santarus reports FDA "is moving along" on its review of an Rx-to-OTC switch application for Zegerid, the firm's immediate-release proton pump inhibitor/antacid product. Schering-Plough filed an application in March for the omeprazole/sodium bicarbonate heartburn drug under a licensing agreement with the San Diego-based firm (1"The Tan Sheet" March 17, 2008, In Brief). Santarus says it is hopeful for approval "somewhere around" early January, CEO Gerald Proehl said during a Nov. 3 quarterly earnings call. If approved, the product will compete with Procter & Gamble's Prilosec OTC, generic omeprazole and other heartburn treatments. Quicker onset claims could give Zegerid an edge over other omeprazole products. For the third quarter ended Sept. 30, prescription Zegerid sales were up 44 percent to $28.1 million. Santarus total revenue was $32.2 million, including a $5 million milestone payment from Schering-Plough. Net loss was $4 million compared with $6.9 million in the prior-year period. The firm adjusted its guidance, projecting a net loss for the year below $8.4 million, down from below $12.5 million

No Prilosec infringement

The U.S. Court of Appeals for the Federal Circuit rules Mylan's generic version of AstraZeneca's heartburn drug Prilosec(omeprazole) does not infringe AstraZeneca's patents. Affirming a 2007 district court decision, the Federal Circuit on June 9 says AstraZeneca failed to prove Mylan's products contained an alkaline reacting compound. Procter & Gamble markets nonprescription omeprazole with Prilosec OTC and Schering-Plough has filed a switch application with FDA for its PPI/antacid combination Zegerid (20 mg omeprazole/1100 mg sodium bicarbonate) (1"The Tan Sheet" March 17, 2008, In Brief)...

Zegerid Switch Application Expected Before May – Santarus

Schering-Plough is expected to file a switch application for Santarus' proton pump inhibitor Zegerid with FDA before May, according to the San Diego-based specialty pharmaceutical firm

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