FDA approves first 3D-printed drug

Aprecia Pharmaceuticals says its individually packed SPRITAM therapy enhances patient adherence by making pills easy to swallow.

For the first time, a drug manufactured via three-dimensional printing (3DP) has been approved by the U.S. Food and Drug Administration.

That’s according to an Aug. 3, 2015 announcement from Aprecia Pharmaceuticals Co. saying that FDA had approved its SPRITAM® levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy. The company says the product will become available by the first quarter of 2016.

The Langhorne, PA-based company says that SPRITAM utilizes Aprecia’s proprietary ZipDose® Technology platform, which uses 3DP to produce a porous formulation that rapidly disintegrates with a sip of liquid.1 While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?