According to Mannkind Corporation, the FDA has informed the company that it will need another four weeks or so before it issues a decision on the NDA for Afrezza inhaled insulin. The original action date was to be December 29, 2010. The FDA issued a complete response letter for the product in March and requested additional data. Read the company’s press release.
Mannkind announces delay on Afrezza decision
published on
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA
