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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech Avastin lung cancer claim clears FDA, while Merck’s new molecular entity Zolinza (vorinostat) is approved for cutaneous T-cell lymphoma. Schering-Plough’s novel antifungal Noxafil (posaconazole) is the first treatment cleared for prevention of invasive Aspergillus infection. Genentech/Biogen Idec’s Rituxan (rituximab) gains a third NHL-related claim with approval of two new indications; Johnson & Johnson’s established anti-TNF agent Remicade (infliximab) expands into the dermatology segment with approval for psoriasis. More approvals in brief

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Approvals In Brief

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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