← FDA DRUG APPROVALS

FDA BLA · BLA022472

AFREZZA

insulin human

Sponsor: MANNKIND

APPLICATION
BLA022472
TYPE
BLA
ORIGINAL APPROVAL
2014-06-27
LATEST ACTION
2026-05-29
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

AFREZZAPrescription
INSULIN RECOMBINANT HUMAN 12 UNITS/INH · POWDER · INHALATION
AFREZZAPrescription
INSULIN RECOMBINANT HUMAN 4 UNITS/INH · POWDER · INHALATION
AFREZZAPrescription
INSULIN RECOMBINANT HUMAN 8 UNITS/INH · POWDER · INHALATION

Approval history

2026-05-29Efficacy · Supplement 29 · standard — Label ↗AP
2026-01-23Efficacy · Supplement 27 · standard — Letter ↗AP
2023-02-03Labeling · Supplement 23 · standard — Label ↗AP
2018-10-25Labeling · Supplement 18 · standard — Label ↗AP
2018-04-24REMS · Supplement 17 — Letter ↗AP
2017-09-29Efficacy · Supplement 11 · standard — Letter ↗AP
2016-04-07Manufacturing (CMC) · Supplement 10 · standardAP
2016-02-17Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2015-09-16Manufacturing (CMC) · Supplement 4 — Label ↗AP
2015-06-24Labeling · Supplement 8 · standard — Letter ↗AP
2015-06-24Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2015-04-20REMS · Supplement 2 — Label ↗AP
2015-04-17Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2015-03-12Labeling · Supplement 5 · standard — Label ↗AP
2014-06-27Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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