UPDATE 1-Vivus resubmits diet drug application to FDA
Oct 17 (Reuters) - Vivus Inc said it resubmitted the approval application for its obesity pill Qnexa to U.S. health regulators.
The U.S. Food and Drug Administration had denied approval for Qnexa last October and asked for evidence that higher heart rate associated with the drug does not increase the risk of major heart problems.
Last month, the FDA had cleared the way for Vivus to submit a new application for a narrower indication that excludes obese women of child-bearing potential.
The resubmission also includes a proposed risk evaluation and mitigation strategy, Vivus said in a statement.
The company's shares closed at $8.58 on Friday on Nasdaq.