Vivus Shares Jump on FDA’s Weight Loss Drug Decision

By | November 19, 2018

Vivus Shares Jump on FDA's Weight Loss Drug Decision

Shares of Vivus shot up more than 14 percent on Monday after the drug maker said U.S. regulators had asked for change to the label of proposed weight-loss pill Qnexa that would allow more women to the product.

The U.S. Food and Drug Administration’s decision would remove a contraindication for women of childbearing age, although a contraindication would remain for pregnant women. Contraindications indicate a drug should not be used since the risk outweighs possible therapeutic benefit.

“The company’s disclosure of this regulatory update should not be interpreted to mean that the potential for FDA approval of Qnexa has improved or that, if approved, that the final Qnexa label would not include contraindications or warnings for specific populations, including women of childbearing potential,” Peter Tam, president of VIVUS, Inc. said in a released statement.

The biotech company has struggled to become the first drug developer to gain FDA approval for a weight drug in more than 10 years.

Last year, the company had announced an agreement with the FDA on a plan that allowed for an early resubmission of the Qnexa New Drug Application which allowed the company to seek approval for an initial indication that included obese men and women of non-childbearing potential.  However VIVUS had resubmitted the weight drug in October and the FDA accepted the new application for review in November.

The company noted that the target date for the health agency to complete its review of the resubmitted Qnexa application is on April 17, 2012.

We picked linked items based on the quality of products, and list the pros and cons of each to help you determine which will work best for you. We partner with some of the companies that sell these products, which means we and our partners may receive a portion of revenues if you make a purchase using a link(s) above.

MUST READ Medical Dictionary :

Other amazing related Dreams you might like:

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

© 2018 Medical Dictionary All rights reserved.

Dream Dictionary | Metroeve Style | Fashion Inspiration & Trends

PRIVACY POLICY | COOKIES POLICY | TERMS OF USE

Disclaimer Medical Dictionary is for informational purposes and should not be considered medical advice, diagnosis or treatment recommendation. Read more