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FDA Clears First 3D Printed Prescription Drug

The FDA has previously approved medical devices made with 3-D printing.

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 Monday 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 3-D 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 3-D 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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