Tetrahydrobiopterin Deficiency

• 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 · 2025-06-11
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s sapropterin dihydrochloride via an original application, adding a new approved product for man…

• 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 · 2025-01-24
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for sapropterin dihydrochloride from Camber Pharmaceuticals, Inc., for its continued marketing a…

• 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 · 2022-09-26
  FDA Approved: JAVYGTOR — Supplemental Application (Dr. Reddys Laboratories Inc)

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

• CLINICAL_TRIALS trial_result · 2020-09-25
  Clinical Trial Update: Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency [Phase 2]

  Phase 2 safety and efficacy study of Phenoptin in subjects with hyperphenylalaninemia due to tetrahydrobiopterin deficiency has completed wi…

• 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…