Phenylketonuria

• FDA approval · 2021-07-26
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Supplemental Application (ENDO USA, Inc.)

  The FDA approved a supplemental application for sapropterin dihydrochloride, updating its approval via ENDO USA, Inc. for use in phenylketon…

• FDA approval · 2021-06-15
  FDA Approved: JAVYGTOR — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddy's Laboratories as an original ANDA, providing a generic option for phenyl…

• FDA approval · 2021-03-30
  FDA Approved: JAVYGTOR — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved JAVYGTOR (sapropterin dihydrochloride) from Dr. Reddy's Laboratories. It is a tetrahydrobiopterin (BH4) analogue used to treat …

• FDA approval · 2020-11-20
  FDA Approved: PALYNZIQ — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved BioMarin's supplemental application for Palynziq (pegvaliase-pqpz), updating the existing approval for phenylketonuria.

• FDA approval · 2020-10-06
  FDA Approved: PALYNZIQ — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved a supplemental application for PALYNZIQ (pegvaliase-pqpz) from BioMarin Pharmaceutical, resulting in changes to the drug's …

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

  FDA approved a supplemental application for sapropterin dihydrochloride submitted by ENDO USA, Inc., marking an additional approval for this…

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

  FDA approved a supplemental application for sapropterin dihydrochloride by ENDO USA, Inc., updating regulatory authorization for this produc…

• FDA approval · 2020-03-16
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved a supplemental application for Kuvan (sapropterin dihydrochloride) by BioMarin Pharmaceutical, updating the product's label…

• FDA approval · 2020-03-16
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

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

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

  FDA approved a supplemental application for Kuvan (sapropterin dihydrochloride) from BioMarin Pharmaceutical, updating its labeling.

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

  FDA approves a generic sapropterin dihydrochloride product under ANDA 210027 (Original Application) by ENDO USA, Inc.

• FDA approval · 2019-05-10
  FDA Approved: SAPROPTERIN DIHYDROCHLORIDE — Original Application (ENDO USA, Inc.)

  The FDA approved the Original Application for sapropterin dihydrochloride from ENDO USA, Inc., authorizing a generic version of the drug.

• FDA approval · 2019-05-02
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved BioMarin's supplemental application for Kuvan (sapropterin dihydrochloride), expanding or updating its labeling for the pro…

• FDA approval · 2019-05-02
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved BioMarin's supplemental application for KUVAN (sapropterin dihydrochloride) submitted by BioMarin Pharmaceutical Inc.

• EMA approval · 2019-03-01
  CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease

  The CHMP recommends authorisation of a new treatment for phenylketonuria, a rare inherited metabolic disease.

• FDA approval · 2019-02-01
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved a supplemental application for Kuvan (sapropterin dihydrochloride) from BioMarin Pharmaceutical Inc. to support treatment of ph…

• FDA approval · 2018-05-24
  FDA Approved: PALYNZIQ — Original Application (BioMarin Pharmaceutical Inc.)

  FDA approved PALYNZIQ (pegvaliase-pqpz) from BioMarin Pharmaceutical for the treatment of adults with phenylketonuria.

• 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 · 2016-06-13
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  The FDA approved BioMarin's supplemental application for Kuvan (sapropterin dihydrochloride), confirming FDA authorization of changes includ…

• FDA approval · 2015-10-28
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved BioMarin's supplemental application for KUVAN (sapropterin dihydrochloride).

• FDA approval · 2014-04-23
  FDA Approved: KUVAN — Supplemental Application (BioMarin Pharmaceutical Inc.)

  FDA approved BioMarin's supplemental application for Kuvan (sapropterin dihydrochloride). The approval updates the drug's labeling and/or ex…

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

  The FDA approved Kuvan (sapropterin dihydrochloride) from BioMarin as the original approval for treatment of phenylketonuria to lower blood …