- Obama takes aim at ‘corporate deserters’
- Dick’s Sporting Goods lays off 478 PGA golf pros
- Senators: Cease-fire must allow Israel to defend against rockets, tunnels
- Sierra Leone doctor fighting Ebola catches disease
- Iraq welcomes Russian fighter jets, helicopter gunships into ISIL fight
- John McCain laments: Obama’s ‘self-pity … is really kind of sad’
- GOP offer to fix VA gives $10 billion in emergency funds
- Paul Ryan offers to repair U.S. economic safety net with a single grant stream
- Kim Jong-un builds bond with Putin: $250M Russia-backed addition to key port opens
- Pope Francis meets Meriam Ibrahim, a Sudanese woman sentenced to death
Highly anticipated weight-loss pill wins approval
Question of the Day
The FDA initially rejected Vivus‘ drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.
The agency also said patients with recent or unstable heart disease or stroke aren’t good candidates for the drug because its effect on heart rates in those patients is not known. Vivus has to do studies of the heart effects of Qsymia, the FDA said.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus plans a slow rollout.
The pill will launch with a relatively small sales force of 150 representatives. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors.
“We’re going to have to grow our sales organization in order to support the primary care market,” Vivus President Peter Tam said in an interview with the Associated Press.
Rival Arena Pharmaceuticals Inc. of San Diego plans to start selling Belviq early next year. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.
TWT Video Picks
By Michael Widlanski
Leveling the battlefield to aid terrorists enables evil to fight on
- Obama orders Pentagon advisers to Ukraine
- 'We're coming for you, Barack Obama': Top U.S. official discloses threat from ISIL terrorists
- NAPOLITANO: What if our democracy is a fraud?
- Hamas rejects Kerry's call for cease-fire; Fears grow others could join fight against Israel
- Norway expects imminent 'concrete threat' from ISIL terrorists 'within days'
- State Department indicates Nouri al-Maliki's days numbered as Iraq prime minister
- Evidence shows Russia firing artillery into Ukraine: Pentagon
- Hamas orders civilians to die in Israeli airstrikes
- Calif. dolls were meant to spread cheer, not chill
- Obama family set to buy $4.25M desert home in California: report
Obama's biggest White House 'fails'
Celebrities turned politicians
Athletes turned actors
20 gadgets that changed the world
Fighting in Iraq