Search Orphan Drug Designations and Approvals
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Generic Name: | manganese (II) chloride tetrahydrate (with L-alanine and vitamin D3 as promoters of absorption) |
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Date Designated: | 09/26/2013 |
Orphan Designation: | Use as a targeted contrast agent for diagnostic MRI for the detection and localization of focal liver lesions in patients where use of gadolinium based contrast agents may be medically inadvisable or where gadolinium based contrast agents cannot be admini |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Ascelia Pharma AB Scion DTU DK-2800 Lyngby Lund Sweden The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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