← FDA DRUG APPROVALS

FDA BLA · BLA125293

KRYSTEXXA

pegloticase

Sponsor: HORIZON PHARMA

APPLICATION
BLA125293
TYPE
BLA
ORIGINAL APPROVAL
2010-09-14
LATEST ACTION
2022-07-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KRYSTEXXAPrescription
PEGLOTICASE 8MG · INJECTABLE · INJECTION

Approval history

2022-07-07Efficacy · Supplement 104 · priority — Letter ↗AP
2018-07-13Labeling · Supplement 92 · standard — Letter ↗AP
2017-08-10Labeling · Supplement 90 · standardAP
2016-09-09Labeling · Supplement 89 · standard — Letter ↗AP
2016-05-10Labeling · Supplement 85 · standard — Label ↗AP
2016-04-11REMS · Supplement 86 — Letter ↗AP
2015-07-30REMS · Supplement 83 — Letter ↗AP
2015-07-17Labeling · Supplement 81 · standard — Letter ↗AP
2013-10-10Labeling · Supplement 60 · standard — Letter ↗AP
2012-04-16Labeling · Supplement 34 · standard — Letter ↗AP
2012-04-16Labeling · Supplement 40 · standard — Label ↗AP
2010-10-19Labeling · Supplement 1 · standard — Letter ↗AP
2010-09-14Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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