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Kuvan Approval History

  • FDA approved: Yes (First approved December 13th, 2007)
  • Brand name: Kuvan
  • Generic name: sapropterin dihydrochloride
  • Dosage form: Tablets
  • Company: BioMarin Pharmaceutical Inc.
  • Treatment for: Phenylketonuria

Kuvan (sapropterin dihydrochloride) is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase to metabolize phenylalanine (Phe). Kuvan is indicated for the treatment of phenylketonuria, an inherited metabolic disease caused by a deficiency of the enzyme phenylalanine hydroxylase.

Development History and FDA Approval Process for Kuvan

Dec 13, 2007Approval BioMarin Announces FDA Approval for Kuvan
Jul 26, 2007Kuvan Receives Priority Review Status from FDA
May 24, 2007BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)

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