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Exubera FDA Approval History

FDA Approved: Yes (Discontinued) (First approved January 27, 2006)
Brand name: Exubera
Generic name: insulin inhalation
Dosage form: Powder
Company: Pfizer Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Marketing Status: Discontinued

Exubera is a rapid-acting, dry powder human insulin inhalation indicated for the treatment of adult patients with diabetes mellitus, either as monotherapy, or in combination with oral agents or longer-acting insulins.

Development timeline for Exubera

Jan 27, 2006Approval Exubera Approved - Pfizer Inc - Treatment for Type 1 and Type 2 Diabetes in Adults
Oct 28, 2005Pfizer and sanofi-aventis Statement on Status of Exubera
Sep 21, 2005BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study
Sep  8, 2005FDA Advisory Committee Recommends Approval of Exubera for Use in Adults With Type 1 and 2 Diabetes
Mar  2, 2005Pfizer and the Sanofi-Aventis Group Seek Approval to Market Exubera in the United States

Further information

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