Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Santarus, a specialty pharmaceutical company, has announced that its partner Schering-Plough HealthCare Products has received a complete response letter from the FDA for its new drug application seeking approval to sell a Zegerid branded omeprazole/sodium bicarbonate product with the dosage strength of 20mg of omeprazole in the US over-the-counter heartburn market.
Subscribe to our email newsletter
The letter outlined questions that the FDA identified during its review of the new drug application (NDA) for over-the-counter (OTC) Zegerid.
Santarus said that it is in regular communication with Schering-Plough who intends to continue to work closely with the FDA on a confidential basis to expeditiously address these questions and secure approval of OTC Zegerid.
As previously disclosed, the NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a licensing agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’s proprietary technology.