← FDA DRUG APPROVALS

FDA BLA · BLA125103

KEPIVANCE

palifermin

Sponsor: BIOVITRUM AB

APPLICATION
BLA125103
TYPE
BLA
ORIGINAL APPROVAL
2004-12-15
LATEST ACTION
2023-07-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KEPIVANCEPrescription
PALIFERMIN 60MCG/KG/DAY · INJECTABLE · INJECTION

Approval history

2023-07-27Labeling · Supplement 186 · standardAP
2019-12-18Labeling · Supplement 176 · standard — Label ↗AP
2016-07-01Labeling · Supplement 172 · standard — Label ↗AP
2016-07-01Labeling · Supplement 171 · standard — Label ↗AP
2016-04-27Labeling · Supplement 170 · standardAP
2015-03-13Labeling · Supplement 167 · standard — Letter ↗AP
2013-05-30Labeling · Supplement 146 · standard — Label ↗AP
2011-11-14Efficacy · Supplement 120 · standard — Label ↗AP
2011-09-23Supplement · Supplement 18 — Label ↗AP
2010-01-21Labeling · Supplement 96 · standardAP
2005-12-12Labeling · Supplement 10 · standard — Label ↗AP
2004-12-15Type 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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