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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Particles comprised ofmethacrylic acid based co-polymer, cross-linked with a bi-functional cross-linker, purified to bind L-phenylalanine and L-phenylalanine containing peptides
Date Designated:  02/27/2020
Orphan Designation:  Treatment of hyperphenylalaninemia
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
MipSalus ApS
AgemAlle 3

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.