The FDA said today that it will miss the January 16 deadline for MannKind's much-watched inhaled insulin drug Afrezza. The agency says it needs more time to complete its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind. The company does not know yet when that inspection will be complete, or when the FDA will announce its ruling on the Afrezza NDA.
MannKind CEO and Chairman Alfred Mann was quick to point out that the FDA had no questions about the drug itself, and that other third-party inspections were completed on schedule. "To our knowledge, all other FDA inspections of third-party suppliers and clinical trial sites are complete, as is the pre-approval inspection of MannKind's manufacturing facility in Danbury, Connecticut. At this time, there are no pending answers to any FDA questions or other deliverables due on MannKind's part," he says in a statement.
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