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Nanotech Meets the FDA: A Success Story about the First Nanoparticulate Drugs Approved by the FDA
Volume 2, Issue 2

Mary C. Till, Foley & Lardner
Michele M. Simkin, Foley & Lardner
Stephen Maebius, Foley & Lardner

As nanotechnology companies emerge in the pharmaceutical market, they will have to develop the capability to navigate through the regulatory waters. Until recently, federal agencies had not faced the question of whether to approve a drug based on nanotechnology. Several companies, however, presented new issues to federal regulators when they developed nanoparticulate drugs and sought approval. In this article, Mary C. Till, Michele M. Simkin and Stephen Maebius examine recent success stories of companies who sought and won approval of these nanoparticulate drugs and outline the approval process for future nanotechnology based drugs. The benefits of formulating a drug as a nanoparticulate drug can be numerous, not only as far as the consumer is concerned, but the developer and manufacturer also can obtain certain exclusivities based on Food and Drug Administration (“FDA”) law as well as other proprietary rights under U.S. patent laws. These recent success stories may be only the beginning of what promises to become many future success stories in the field of nanotech based drugs.

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