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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125103
Company: BIOVITRUM AB

Other Important Information from FDA

Products on BLA 125103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEPIVANCE	PALIFERMIN	60MCG/KG/DAY	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2004	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125103_0000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125103s000_KepivanceTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2023	SUPPL-186	Supplement		Label is not available on this site.
12/18/2019	SUPPL-176	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125103s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125103Orig1s176ltr.pdf
07/01/2016	SUPPL-172	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf
07/01/2016	SUPPL-171	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125103Orig1s171,s172ltr.pdf
04/27/2016	SUPPL-170	Supplement		Label is not available on this site.
03/13/2015	SUPPL-167	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125103Orig1s167ltr.pdf
05/30/2013	SUPPL-146	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125103s146lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125103Orig1s146ltr.pdf
11/14/2011	SUPPL-120	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125103s0120ltr.pdf
01/21/2010	SUPPL-96	Supplement		Label is not available on this site.
09/23/2011	SUPPL-18	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0118lbl.pdf
12/12/2005	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125103s0010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125103s0010ltr.pdf

Labels for BLA 125103

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2019	SUPPL-176	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125103s176lbl.pdf
07/01/2016	SUPPL-172	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf
07/01/2016	SUPPL-171	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125103s171s172lbl.pdf
05/30/2013	SUPPL-146	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125103s146lbl.pdf
11/14/2011	SUPPL-120	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0120lbl.pdf
09/23/2011	SUPPL-18	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125103s0118lbl.pdf
12/12/2005	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125103s0010lbl.pdf
12/15/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125103lbl.pdf

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