MR contrast developer Epix Pharmaceuticals has received an approvable letter from the U.S. Food and Drug Administration for its MS-325 MR blood pool contrast agent.
The FDA has requested additional clinical studies to demonstrate efficacy, however, prior to approval, according to the Cambridge, MA-based vendor. Epix said that the agency's principal questions relate to the noncontrast MRA comparator scans used in the phase III trials, and to the statistical treatment of uninterpretable images.
The letter identified no safety or manufacturing deficiencies. Epix said it is continuing an active dialogue with the FDA to determine the next steps needed to gain approval for MS-325.
By AuntMinnie.com staff writers
January 14, 2005
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Epix names Uprichard president and COO, July 16, 2004
Epix testing MS-325 for cardiac imaging, July 12, 2004
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