An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 205065
Company: BIOMARIN PHARM

Summary Review

Products on NDA 205065

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	AB	Yes	Yes
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205065

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205065Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s018,205065Orig1s007ltr.pdf
03/16/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022181Orig1s020, 205065Orig1s006ltr.pdf
05/02/2019	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s019, 205065Orig1s005ltr.pdf
08/09/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205065Orig1s002ltr.pdf
10/28/2015	SUPPL-1	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf

Labels for NDA 205065

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf
12/13/2019	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
12/13/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf
05/02/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
05/02/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf
08/09/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf
10/28/2015	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf
12/19/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf

Therapeutic Equivalents for NDA 205065

KUVAN

POWDER;ORAL; 100MG/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	Yes	AB	205065	BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	215420	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	209452	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	100MG/PACKET	POWDER;ORAL	Prescription	No	AB	207207	PAR PHARM INC

POWDER;ORAL; 500MG/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KUVAN	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	Yes	AB	205065	BIOMARIN PHARM
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	215420	ANNORA PHARMA
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	215798	DR REDDYS
SAPROPTERIN DIHYDROCHLORIDE	SAPROPTERIN DIHYDROCHLORIDE	500MG/PACKET	POWDER;ORAL	Prescription	No	AB	210027	PAR PHARM INC

Top