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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021839
Company: IPSEN INC

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 021839

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INCRELEX	MECASERMIN RECOMBINANT	40MG/4ML (10MG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021839

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2005	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021839ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021839_IncrelexTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2024	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021839s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021839Orig1s031ltr.pdf
10/20/2023	SUPPL-27	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021839Orig1s027ltr.pdf
12/03/2019	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021839Orig1s024ltr.pdf
01/18/2019	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021839Orig1s021ltr.pdf
03/15/2016	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021839Orig1s017ltr.pdf
06/03/2014	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021839Orig1s016ltr.pdf
01/16/2013	SUPPL-14	Supplement		Label is not available on this site.
06/14/2012	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839s012ltr.pdf
09/13/2012	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021839Origs010ltr.pdf
02/16/2011	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021839s007ltr.pdf

Labels for BLA 021839

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2024	SUPPL-31	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021839s031lbl.pdf
10/20/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf
10/20/2023	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf
10/20/2023	SUPPL-27	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021839s027lbl.pdf
12/03/2019	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s024lbl.pdf
01/18/2019	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021839s021lbl.pdf
03/15/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf
06/03/2014	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021839s016lbl.pdf
09/13/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s010lbl.pdf
06/14/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021839s012lbl.pdf
02/16/2011	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf
02/16/2011	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021839s007lbl.pdf
08/30/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021839lbl.pdf

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