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- Title
Dreamboat sinks prospects for fast approval of inhaled insulin.
- Authors
Kling, Jim
- Abstract
The article reports on the complete response letter issued by the U.S. Food and Drug Administration (FDA) to MannKind asking for additional data on its inhaled insulin product called Afrezza in March 2011, a move which could end the possibility of inhaled insulin. It says that the FDA requested more details on the bioequivalence of the second-generation inhaler device called Dreamboat and the MedTone inhaler used in clinical trials. According to the author, MannKind switched to Dreamboat because of the significant advantages that it offers.
- Subjects
UNITED States; UNITED States. Food &; Drug Administration; MANNKIND Corp.; RESPIRATORY therapy; INHALERS; CLINICAL trials
- Publication
Nature Biotechnology, 2011, Vol 29, Issue 3, p175
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0311-175