Vivus Submits Document to FDA

Vivus (NASDAQ: [[ticker:VVUS]]), the Mountain View, CA-based based obesity drug developer, said today it has submitted a briefing document to the FDA to answer questions the agency raised when it turned down the company’s new drug application in October. The company said it has also gotten a meeting scheduled with the FDA for late January to discuss what would need to be part of its resubmitted application for phentermine/topiramate (Qnexa).

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.