The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind’s Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July 15, 2014.
The delay was necessary “in order to provide time for a full review of information submitted by MannKind in response to the FDA’s requests,” the company said. While the EMDAC votes were nearly unanimous in affirming Afrezza’s efficacy and safety, the FDA has raised questions about the efficacy and safety of the product.
Read the MannKind press release.
