FDA Approves First 3D Printed Drug: Levetiracetam

In a first, the Food and Drug Administration has given approval to a drug that is produced on a 3-D printer. The pill, produced by Aprecia Pharmaceuticals, treats seizures. It’s expected to hit the market in the first quarter of 2016.

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 technology allows the formulation to quickly disintegrate with a sip of liquid. However the precise mechanism by which Levetiracetam exerts its antiepileptic effect is unknown. It will be available as 250mg, 500mg, 750mg, and 1000mg strengths in a spearmint flavor and is expected to be available for prescription in the first quarter of 2016.