Search Orphan Drug Designations and Approvals
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Generic Name: | pegvaliase-pqpz | ||||||||||||||||
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Trade Name: | PALYNZIQ | ||||||||||||||||
Date Designated: | 03/08/1995 | ||||||||||||||||
Orphan Designation: | Treatment of hyperphenylalaninemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, California 94949 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | pegvaliase-pqpz |
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Trade Name: | PALYNZIQ | |
Marketing Approval Date: | 05/24/2018 | |
Approved Labeled Indication: | Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management | |
Exclusivity End Date: | 05/24/2025 | |
Exclusivity Protected Indication* : | Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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