Vivus Submits Document to FDA

Vivus (NASDAQ: VVUS), the Mountain View, CA-based based obesity drug developer, said today it has submitted a briefing document to the FDA to answer questions the agency raised when it turned down the company’s new drug application in October. The company said it has also gotten a meeting scheduled with the FDA for late January to discuss what would need to be part of its resubmitted application for phentermine/topiramate (Qnexa).

Trending on Xconomy

By posting a comment, you agree to our terms and conditions.

2 responses to “Vivus Submits Document to FDA”

  1. icantknow says:

    On the biotech, it is wierd how a company like VVUS went up, when OREX got the FDA Advisory panel approval 13-9… I recall that at the end of that OREX panel, 2 of the members said they were going to vote no before voting yes after a post-marketing research question. My point is, this could have been an 11-11 by a hair. And that was the same comment made by the panel a few times how Orexigen research made it by a hair for one of the two requirements. (I’m pretty sure of my comment validity, but don’t take my word for it)… VVUS and ARNA were told to go back to the research by the FDA. ARNA tanked after that, and VVUS is up. Sure their is enthusiasm with OREX squaking by the Advisory Committee, but VVUS has a long way to go, and a huge risk to me, and pre-mature to think to buy it now. It could take a year to even get to the POSSIBILITY of approval. . wayyy down the road.

  2. icantknow says:

    This publication had the article on October 29th (link on this page) “Vivus turned down by FDA” And the problems have not changed for VVUS quoting

    ” The agency, in a complete response letter to the company, requested a “comprehensive assessment” on whether the Vivus therapy, a combination of phentermine and topiramate (Qnexa), is linked to birth defects or miscarriages. The company said it plans to respond to the FDA’s questions in writing in about six weeks. The rejection is no big surprise, given that an FDA advisory panel in July recommended the application be turned down”