The U.S. FDA has declined to approve contrast developer Advanced Magnetics’ supplemental new drug application (sNDA) for Feridex I.V. The agent was first approved in August 1996 as an MR contrast agent for the detection of liver lesions.
The Cambridge, MA-based company submitted the sNDA in December 2000, seeking an expanded indication and a more convenient dosing regimen for Feridex I.V. In its written response, the FDA said the data provided in the supplement were insufficient to support the additional labeling claims.
By AuntMinnie.com staff writersAugust 31, 2001
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