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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022472
Company: MANNKIND

Medication Guide

REMS

Summary Review

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

Products on BLA 022472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AFREZZA	INSULIN RECOMBINANT HUMAN	4 UNITS/INH	POWDER;INHALATION	Prescription	None	No	No
AFREZZA	INSULIN RECOMBINANT HUMAN	8 UNITS/INH	POWDER;INHALATION	Prescription	None	No	No
AFREZZA	INSULIN RECOMBINANT HUMAN	12 UNITS/INH	POWDER;INHALATION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 022472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2014	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2023	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022472s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022472Orig1s023ltr.pdf
10/25/2018	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s018ltr.pdf
04/24/2018	SUPPL-17	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s017ltr.pdf
09/29/2017	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022472Orig1s011ltr.pdf
04/07/2016	SUPPL-10	Supplement		Label is not available on this site.
02/17/2016	SUPPL-9	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf
06/24/2015	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf
06/24/2015	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf
03/12/2015	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s005ltr.pdf
09/16/2015	SUPPL-4	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf
04/17/2015	SUPPL-3	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf
04/20/2015	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s002ltr.pdf

Labels for BLA 022472

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022472s023lbl.pdf
02/03/2023	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022472s023lbl.pdf
02/03/2023	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022472s023lbl.pdf
10/25/2018	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf
10/25/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf
09/29/2017	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf
02/17/2016	SUPPL-9	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf
09/16/2015	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf
06/24/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf
06/24/2015	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf
06/24/2015	SUPPL-6	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf
04/20/2015	SUPPL-2	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf
04/17/2015	SUPPL-3	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf
03/12/2015	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf
06/27/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf

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