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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: L-serine, L-threonine, L-leucine, glycine, L-alanine, L-arginine, L-cysteine, L-glutamine, L-histidine, L-aspartic acid, L-proline, L-isoleucine, L-lysine, L-tryptophan, L-valine, L-methionine, L-tyrosine, carnitine and taurine
Date Designated: 03/23/2020
Orphan Designation: Treatment of phenylketonuria
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
APR Applied Pharma Research
Via Corti 5
Balerna
Switzerland

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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