Vivus to Try Again By Year’s End

Vivus (NASDAQ: 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.

Trending on Xconomy