FDA Setting Up Shop in China
The FDA is establishing three permanent offices in China to monitor drug safety, which will be staffed by eight FDA employees along with five Chinese nationals to assist them.
The State Department has approved the plan, but the Chinese government has yet to do so. The posts are to be established by September 2009 at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou as part of the agency’s Beyond our Borders initiative.
This region is the first of at least five where the FDA intends to establish an overseas presence, FDA Commissioner Andrew von Eschenbach said. India, Europe, South America and the Middle East also are on the list. FDA spokeswoman Stephanie Kwisnek said the regions are listed in no particular order. The new FDA offices in China will give the agency greater access to local manufacturing facilities for inspections and improve its interactions with Chinese manufacturers, helping ensure that food and drug products shipped to the U.S. meet its standards for safety and manufacturing quality. (source: FDA newsletter)
Schering-Plough Files Application for OTC Heartburn Drug
Schering-Plough has submitted a new drug application for 20-mg Zegerid as an OTC product to treat frequent heartburn.
The company acquired exclusive U.S. and Canadian rights to market OTC proton pump inhibitor products using proprietary technology under a 2006 license agreement with Santarus.
Under the agreement, Santarus received a $15 million upfront license fee and is entitled to an additional $65 million in milestone payments. Santarus continues to manufacture and sell Zegerid (omeprazole/sodium bicarbonate) prescription products in both 20- and 40-mg strengths in the U.S. The U.S. OTC heartburn market generated an estimated $1.6 billion sales in 2007, based on data from market research firm A.C. Nielsen and Santarus’ calculations. (source: FDA newsletter)
