This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryPfizer's inhaled insulin product Exubera is not a new molecular entity, according to FDA. Prior to the agent's January approval, the sponsor had referred to Exubera as a "new chemical compound" in filings with the Securities & Exchange Commission. Exubera "is native sequence human insulin and therefore is not technically an NME," according to FDA's Office of Drug Evaluation II. "The insulins that are NMEs…have different amino acid sequences," FDA explains. The most recently approved NME insulin is Novo Nordisk's Levemir (insulin detemir), approved in June 2005 (1Pharmaceutical Approvals Monthly July 2005, p. 15); prior to that, Sanofi-Aventis' Apidra (insulin glulisine) was cleared as an NME in April 2004. Exubera is the first inhaled insulin to clear FDA...
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