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

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

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.cfm
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

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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