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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Exubera is first inhaled insulin: Pfizer's inhaled insulin Exubera - the first of its kind - is not meant as a replacement for injectable insulins, even though it allows recipients to reach peak insulin concentrations more quickly, FDA Center for Drug Evaluation & Research Director Steven Galson emphasizes in announcing approval Jan. 27. Pfizer plans to launch the product by summer. Exubera, a short-acting insulin, is indicated for "the treatment of adult patients with diabetes mellitus for the control of hyperglycemia." In patients with type 1 diabetes, Exubera should be used with longer-acting insulin. In patients with type 2 diabetes, Exubera can be used as monotherapy or in combination with oral agents or longer-acting insulins, labeling states. A recommendation for patients to get lung function tests every six to 12 months will continue until the agency has more information on Exubera's effect on the lungs from post-marketing studies. Pfizer acquired Sanofi-Aventis' marketing rights to Exubera for $1.3 bil. in January, building on the firms' previous co-development alliance (1Pharmaceutical Approvals Monthly January 2006, p. 42)...

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Licensing In Brief

Pfizer ups ante on Exubera approval with full license: Pfizer's decision to acquire Sanofi-Aventis' marketing rights to Exubera suggests the company is confident that the inhaled insulin product will receive FDA approval. Exubera's user fee date is Jan. 27, following a three-month extension resulting from an FDA request for additional technical chemistry data. Pfizer announced Jan. 12 that it will acquire worldwide rights for the development, production and commercialization of Exubera for $1.3 bil. - building on the firms' previous co-development alliance. The deal follows a judge's ruling that Sanofi's purchase of Aventis constituted a change-in-control under Pfizer and Aventis' 1998 agreement for Exubera. The NDA was submitted in March (1Pharmaceutical Approvals Monthly March 2005, p. 12)...

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