Phenylketonuria

• FDA approval · 2013-12-19
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved a supplemental application for KUVAN (sapropterin dihydrochloride) submitted by BioMarin Pharmaceutical, resulting in updated l…

• FDA approval · 2013-11-22
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved a supplemental application for KUVAN (sapropterin dihydrochloride) submitted by BioMarin, resulting in an updated labeling for …

• FDA approval · 2013-01-23
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved a supplemental application for KUVAN (sapropterin dihydrochloride) from BioMarin Pharmaceutical, signaling an update to its…

• FDA approval · 2008-06-20
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved a supplemental application for Kuvan (sapropterin dihydrochloride) by BioMarin Pharmaceutical Inc.

• CLINICAL_TRIALS approval · 2008-04-15
  Clinical Trial Update: Sapropterin Expanded Access Program

  Sapropterin (Kuvan) has been approved for marketing for phenylketonuria under an expanded access program.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2007-12-13
  FDA Approved: KUVAN — Original Application (BioMarin Pharmaceutical Inc.)

  FDA approved Kuvan (sapropterin dihydrochloride) from BioMarin as an original application for the treatment of phenylketonuria, to improve t…