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News From the Food and Drug Administration
September 15, 2015

The Printed Pill

JAMA. 2015;314(11):1108. doi:10.1001/jama.2015.10976

In early August, the FDA approved the first drug made with 3-dimensional printing technology. The medication, marketed as Spritam, is an oral formulation of levetiracetam that is indicated as an adjunctive therapy for partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in children and adults with epilepsy (http://bit.ly/1ILlGDU).

Aprecia Pharmaceuticals Company, which is headquartered in Langhorne, Pennsylvania, manufactures Spritam with its proprietary ZipDose Technology platform. Based on research developments at the Massachusetts Institute of Technology in the late 1980s, the platform repeatedly spreads thin layers of powdered medication on top of one another while liquid droplets are printed onto specific regions of each layer to bond them together (http://bit.ly/1ILi72F).