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news.US based Vivus is planning to resubmit Qnexa new drug application (NDA) for the treatment of obesity under an agreement with the Endocrine and Metabolic Division of the Food and Drug Administration (FDA).
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With this plan, the company expects to seek approval for an initial indication that includes obese men and women of non-child bearing potential.
The company intends to refile the NDA by the end of October 2011, prior to completion of the Fortress study.
Vivus president Peter Tam said the planned October resubmission will also allow for an early 2012 Advisory Committee meeting and a second quarter 2012 PDUFA date.
"If the Fortress results are favorable, we expect to file for the full indication in late 2012," Tam said.