Vivus (NASDAQ: [[ticker:VVUS]]), the Mountain View, CA-based developer of an obesity drug, said today it hopes to resubmit its new drug application to the FDA for phentermine and topiramate (Qnexa) by the end of the year. The first application from Vivus was shot down by the FDA in October, when the FDA asked for an assessment of whether the drug was linked to any increased risk of miscarriages or birth defects. The company, after meeting with the FDA to discuss its concerns, offered more information in January about how the agency was looking for increased risks of oral clefts, or cleft palates in newborns from women who got one of the key ingredients in the Vivus weight loss drug.
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.
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