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U.S. Department of Health and Human Services

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)
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
Ascelia Pharma AB
Scion DTU
DK-2800 Lyngby

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.