Drug/indication: Afrezza for diabetes
Approval decision date: UnknownThe Jan. 16 FDA approval decision date for Afrezza was extended because inspections at an insulin manufacturing facility were not yet completed, according to Mannkind. How long the FDA will take to complete its inspection and issue an approval decision for Afrezza, an inhaled insulin device, is not known. Last month, Mannkind executives expressed confidence that the FDA would be able to complete its review within weeks, but that timeline is already past due.
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