Medical Letter on the CDC & FDA
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC & FDA
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Diagnostics
Company gets receipt of approvable letter from FDA for MS-325
February 20th, 2005
EPIX Pharmaceuticals, Inc., (EPIX), announced that the U.S. Food and Drug Administration (FDA) has completed its review of the new drug application for MS-325 (gadofosveset trisodium), and found it to be approvable. In the approvable letter, the FDA requested additional clinical studies to demonstrate efficacy prior to approval. MS-325 is the first in a new class of magnetic resonance imaging (MRI) blood pool contrast agents, and is specifically designed for magnetic resonance angiography (MRA). The FDA indicated that its principal questions continue to relate to the noncontrast MRA comparator scans used in the phase III trials and to the statistical...
Source: Medical Letter on the CDC & FDA (2005-02-20)
|
