NDA 022181

BIOMARIN PHARM

FDA Drug Application

Application #022181

Documents

• Letter: 2008-06-24
• Letter: 2013-12-20
• Label: 2007-12-13
• Summary Review: 2008-07-22
• Letter: 2007-12-13
• Letter: 2013-12-20
• Letter: 2014-04-24
• Letter: 2016-06-15
• Label: 2013-12-23
• Label: 2013-12-23
• Label: 2015-11-10
• Label: 2016-06-17
• Review: 2008-03-24
• Questions and Answers: 2007-12-13
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Written Request: 2014-03-28
• Pediatric Amendment 1: 2014-03-13
• Label: 2019-02-04
• Letter: 2019-02-13
• Label: 2019-05-03
• Letter: 2019-05-03
• Label: 2019-12-16
• Letter: 2019-12-17
• Label: 2020-03-17
• Letter: 2020-03-17

Application Sponsors

NDA 022181

BIOMARIN PHARM

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

1

KUVAN

SAPROPTERIN DIHYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2007-12-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-01-23	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2013-12-19	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2013-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-11-22	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	2014-04-23	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2016-06-13	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-02-01	STANDARD
LABELING; Labeling	SUPPL	18	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-05-02	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-03-16	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	7	Null	0
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	12	Null	0
SUPPL	13	Null	8
SUPPL	14	Null	6
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	6

TE Codes

001

Prescription

AB

CDER Filings

BIOMARIN PHARM

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(
    [0] => Array
        (
            [ApplNo] => 22181
            [companyName] => BIOMARIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"KUVAN","activeIngredients":"SAPROPTERIN DIHYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/16\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022181s020,205065s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022181s018,205065s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022181s018,205065s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022181s019,205065s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022181s019,205065s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022181s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2016","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022181s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2014","submission":"SUPPL-13","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022181s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2013","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022181s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2013","submission":"SUPPL-9","supplementCategories":"Efficacy-New Route Of Administration","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022181s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022181lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"KUVAN","submission":"SAPROPTERIN DIHYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-03-16
        )

)