MannKind: FDA Approves Label Update To Prescribing Information For Afrezza

January 26, 2026 — 06:23 am EST

Written by RTTNews.com for RTTNews

(RTTNews) - MannKind (MNKD) announced that the FDA has approved an update to the Prescribing Information for Afrezza Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. The updated labeling was supported by modeling data and in vivo results from the Dose Optimization study and the INHALE-3 trial.

"We expect that this label update will help support healthcare providers by providing clearer starting dose guidance when transitioning patients to inhaled insulin from subcutaneous mealtime insulinwhether injections or insulin pumps," said Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Diabetes at MannKind.

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MannKind: FDA Approves Label Update To Prescribing Information For Afrezza

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