An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 103950
Company: BIOVITRUM AB

Products on BLA 103950

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KINERET	ANAKINRA	10MIU/VIAL	VIAL; SUBCUTANEOUS	Prescription	None	No	No
KINERET	ANAKINRA	18MIU/VIAL	VIAL; SUBCUTANEOUS	Prescription	None	No	No
KINERET	ANAKINRA	25MIU/VIAL	VIAL; SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103950

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2001	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter Patient Package Insert (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/anakamg111401L.htm https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401ptLB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/103950-0_Kineret.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2020	SUPPL-5189	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103950s5189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103950Orig1s5189ltr.pdf
02/02/2020	SUPPL-5183	Supplement		Label is not available on this site.
06/07/2018	SUPPL-5182	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103950s5182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103950Orig1s5182ltr.pdf
11/16/2016	SUPPL-5177	Supplement		Label is not available on this site.
05/19/2016	SUPPL-5175	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103950s5175lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103950Orig1s5175ltr.pdf
10/23/2013	SUPPL-5150	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103950Orig1s5150ltr.pdf
12/21/2012	SUPPL-5136	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103950Orig1s5136ltr.pdf
09/23/2011	SUPPL-5116	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103950s5116lbl.pdf
10/31/2008	SUPPL-5079	Supplement		Label is not available on this site.
12/15/2006	SUPPL-5064	Supplement		Label is not available on this site.
02/22/2006	SUPPL-5061	Supplement		Label is not available on this site.
08/09/2005	SUPPL-5058	Supplement		Label is not available on this site.
04/23/2004	SUPPL-5039	Supplement	Label (PDF) Letter (PDF) Patient Package Insert (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103950_5039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039ppi.pdf
08/22/2003	SUPPL-5019	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103950-5019ltr.pdf
06/27/2003	SUPPL-5013	Supplement	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/anakamg062703LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/anakamg062703L.htm

Labels for BLA 103950

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2020	SUPPL-5189	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103950s5189lbl.pdf
06/07/2018	SUPPL-5182	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103950s5182lbl.pdf
05/19/2016	SUPPL-5175	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103950s5175lbl.pdf
10/23/2013	SUPPL-5150	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103950s5150lbl.pdf
12/21/2012	SUPPL-5136	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103950s5136lbl.pdf
09/23/2011	SUPPL-5116	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103950s5116lbl.pdf
04/23/2004	SUPPL-5039	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103950s5039lbl.pdf
06/27/2003	SUPPL-5013	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/anakamg062703LB.pdf
11/14/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/anakamg111401LB.pdf

Top