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FDA Approves 3D-Printed Drug

Accepted submission by takyon at 2015-08-04 22:39:56
Techonomics

The U.S. Food and Drug Administration (FDA) has given its first approval to a 3D-printed drug. Aprecia Pharmaceuticals has created a new version of Spritam (levetiracetam) [npr.org], a seizure medication, and it is expected to hit the market in Q1 2016:

The FDA had previously approved medical devices made with 3-D printing. The company that makes Spritam says the 3-D-printed version of the drug allows it to dissolve more quickly, which makes it easier to swallow.

Another benefit of the process, says Aprecia, the drug's maker, is that it allows a high drug load — up to 1,000 mg — to be delivered in a single dose. The 3-D printing process creates a pill that has "a porous formulation that rapidly disintegrates with a sip of liquid," the company says.

Aprecia says it based its printing platform on technology that originated at the Massachusetts Institute of Technology.

The FDA has previously approved 3D-printed medical devices, but no 3D-printed drugs. Levetiracetam [wikipedia.org] is available as a generic medicine in the U.S. and UK.


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