Photo

Reuters Photojournalism

Our day's top images, in-depth photo essays and offbeat slices of life. See the best of Reuters photography.  See more | Photo caption 

Photo

Gettysburg's 150th

Re-enactors and visitors mark the 150th anniversary of the Battle of Gettysburg, often described as the turning point of the Civil War.  Slideshow 

Photo

Gay pride parades

Revelers celebrate in gay pride parades around the world, on the heels of twin victories on same-sex marriage in the U.S. Supreme Court.  Slideshow 

Sponsored Links

FDA rejects Merck's insomnia drug

Related Topics

Mon Jul 1, 2013 8:24am EDT

(Reuters) - Merck & Co Inc said the U.S. Food and Drug Administration rejected the company's experimental insomnia drug, citing safety issues.

In a complete response letter to the company, the FDA said the safety data of the drug do not support approval, and advised that lower doses of the medicine should be made available before an approval.

The efficacy of the drug, suvorexant, was established at doses of 10 mg to 40 mg in adults, the FDA said, adding that 10 mg should be the starting dose for most patients.

(Reporting by Esha Dey in Bangalore)

 
We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/
Comments (0)
Be the first to comment on reuters.com.
Add yours using the box above.