Hyperphenylalaninemia

• FDA approval · 2026-01-08
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Micro Labs Limited)

  FDA approves an original-application Abbreviated New Drug Application for sapropterin dihydrochloride by Micro Labs Limited. This approval m…

• FDA approval · 2025-09-03
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (TRUPHARMA, LLC)

  FDA approved the original application for sapropterin dihydrochloride from Trupharma, LLC, for the treatment of phenylketonuria by reducing …

• FDA approval · 2025-04-03
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' sapropterin dihydrochloride, establishing a generic version of the treat…

• FDA approval · 2025-02-28
  FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)

  FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddys Laboratories Inc.

• FDA approval · 2024-03-15
  FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)

  The FDA approved a supplemental application for JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddys Laboratories Inc.

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• FDA approval · 2020-09-09
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (ENDO USA, Inc.)

  The FDA approved a supplemental application for sapropterin dihydrochloride from Endo USA, Inc., indicating an update to the product’s label…

• FDA approval · 2019-12-13
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved BioMarin's supplemental application for KUVAN (sapropterin dihydrochloride), resulting in an approved update to its labelin…

• FDA approval · 2019-08-20
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (ENDO USA, Inc.)

  FDA approved an original Abbreviated New Drug Application for sapropterin dihydrochloride from ENDO USA, Inc., enabling a generic option for…

• FDA approval · 2016-08-09
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

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

• 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 …