Main > MEDICINE > Medical Diagnostics > Imaging Diagnostics > Magnetic Resonance AngioGraphy > Contrast Agents > Co.: DE. B. (Brand/Inj./Patents) > Status>USA

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Co. today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the company s appeal for immediate approval of GadoFosVeset Tri-
Na Inj. In this response, the FDA, while denying the immediate approval of GadoFosVeset Tri-
Na Inj., indicated that further clinical trials may not be necessary to gain approval. The FDA had previously indicated that one or two additional pivotal clinical trials would be required for approval. Instead, the FDA now stated that a blinded re-read of the images obtained from the previously completed Phase 3 clinical trials of GadoFosVeset Tri-
Na Inj. could support approval of GadoFosVeset Tri-
Na Inj. if the results are positive


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