• Most Popular
  • Most Shared

Merck says FDA seeks more data on Emend injection

Fri May 11, 2007 4:59pm EDT

Stocks

   

CHICAGO, May 11 (Reuters) - Merck & Co. (MRK.N) on Friday said U.S. regulators want more data on its experimental injectable drug for nausea caused by chemotherapy, before granting approval for the treatment.

Regulatory News

The drugmaker said the U.S. Food and Drug Administration has requested additional manufacturing and stability data, among other data sought, before it will clear the injectable drug for sale.

Once Merck responds to the so-called approvable letter from the FDA, review is expected to take six months, the company said.

Merck said the request does not affect the manufacturing and availability of an oral form of the drug, which the agency approved last year for post-operative nausea.



More from Reuters

Photo

World stocks push higher in pre-Xmas rally

PARIS (Reuters) - World stocks extended gains to their highest level in almost three weeks on Thursday while oil also gained as investors confident of a strong global economic recovery into 2010 chased risky assets in pre-Christmas trade. | Video

Senate Majority Leader Harry Reid (D-NV) addresses senate health care legislation in a news conference at the US Capitol in Washington, December 19, 2009. REUTERS/Jonathan Ernst

Reid delivers on healthcare

Party-line Senate vote passes bill that would extend health coverage to tens of millions of uninsured Americans, but it's not law yet.  Full Article 

A security guard walks past cars in a Geely Automobile Holdings Ltd. factory in a Shanghai suburb September 28, 2006.REUTERS/Aly Song

China in auto power play

It might not shake up the industry just yet, but China's interest in Volvo and Saab is the start of something big in global autos.  Commentary | Video