Aprecia Pharmaceuticals

FDA approves first 3D printed drug product

Wednesday, August 5, 2015

The FDA has approved Aprecia Pharmaceuticals’ 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. SPRITAM utilizes Aprecia’s proprietary ZipDose Technology platform, which uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. 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.

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