Schering: Approvable letter for new contrast agent MS-325
Schering AG announced that its development partner, EPIX Pharmaceuticals, Inc., 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.
MS-325 was co-developed under a strategic partnership with EPIX and Schering has the global marketing rights for the product. Schering has also submitted MS-325 for approval in Europe.
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