Skip to Content

Exubera Approval History

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

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 History and FDA Approval Process for Exubera

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide