FDA review documents for Amgen's epidermal growth factor receptor inhibitor Vectibix (panitumumab) outline possible factors that may have led to the biologic's failure to show an overall survival benefit in a pivotal trial.

Berlex's oral contraceptive Yaz (drospirenone/ethinyl estradiol) clears FDA Jan. 26 for the treatment of moderate acne vulgaris in women who desire an oral contraceptive for birth control. Based on two six-month trials in more than 1,000 patients, the oral contraceptive showed significant reduction in inflammatory and noninflammatory lesion counts. The approval marks the third indication for Yaz, which is also indicated for treatment of emotional and physical symptoms of premenstrual dysphoric disorder (1Pharmaceutical Approvals Monthly October 2006, p. 5)...

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)...