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...