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Diagnostics
Approvable letter issued for new contrast agent MS-325
February 20th, 2005
Schering AG, Germany (SCH, SHR) announced that its development partner, Epix Pharmaceuticals, Inc., (Epix), has received an approvable letter from the U.S. Food and Drug Administration (FDA) for MS-325 (gadofosveset trisodium). MS-325 is anticipated to be the first in a new class of blood pool contrast agents for magnetic resonance angiography (MRA) to diagnose vascular disease. In the approvable letter, the FDA requested additional studies to support the application for MS-325 in enhanced MRA. "We believe that MS-325 has the potential to be an important advancement for the medical community in the non-invasive diagnosis of...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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