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Closing the gap for generic nanomedicines

from Chemical & Engineering News

In October 2011, drug shortages were such a pressing issue in the U.S. that President Barack Obama issued an executive order urging the Food & Drug Administration to streamline the approval process for new therapeutics that could fill the voids. One of the more noticeable voids was in the supply of Doxil, a nanoparticle chemotherapy drug. To curb this shortage, FDA authorized the temporary importation of an Indian Doxil copycat called Lipodox in February 2012. In keeping with the executive order, the agency evaluated and approved the drug formulation within a year, roughly one-third of the time it takes for an average generic medicine to receive approval. Doxorubicin hydrochloride liposome injection became what many consider to be the first generic nanodrug approved in the U.S. more


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