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FDA clears 3D printed tablet for epileptic seizures

Aprecia Pharmaceuticals’ drug Spritam approved for adults and children.


August 4, 2015
by ASSOCIATED PRESS

WASHINGTON — The Food and Drug Administration has approved the first prescription drug made through 3-D printing: a dissolvable tablet that treats seizures.

Aprecia Pharmaceuticals said the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured in a layered process via 3D printing and dissolves when taken with liquid.

The FDA has previously approved medical devices – including prosthetics – made with 3-D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process.

Doctors are increasingly turning to 3D printing to create customized implants for patients with rare conditions and injuries. The FDA held a workshop last year for medical manufacturers interested in the technology.

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