- Aprecia announces availability of 3D-printed drug Spritam (drugstorenews.com)
Aprecia Pharmaceuticals announced the U.S. availability of its Spritam (levetiracetam) tablets...The epilepsy medication is the first tablet made using the company’s ZipDose 3D printing technology to be approved by the Food and Drug Administration. It is designed to dissolve with a sip of liquid, easing the process of taking medication for patients with difficulty swallowing...
- FDA revokes approval for Sun Pharma’s seizure drug over compliance issues (reuters.com)
Food and Drug Administration has revoked an approval issued in March to India's Sun Pharma Advanced Research Company Ltd to launch a drug (Elepsia XR, levetiracetam), for seizures, citing manufacturing quality problems at its production site…setback to SPARC, the research arm of India's largest drugmaker,…FDA issued it a "Complete Response Letter" in which it said "the compliance status of the manufacturing facility was not acceptable on the date of approval".
- FDA Clears First 3D-Printed Drug (Spritam [Levetiracetam]) (medscape.com)Aprecia Preps to 3D Print Medicine with New Facility (video) (3dprintingindustry.com)
Food and Drug Administration has approved the first three-dimensional printed oral drug product, Spritam (levetiracetam), from Aprecia Pharmaceuticals,…indicated as adjunctive therapy for partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children with epilepsy…was developed with Aprecia's proprietary ZipDose technology, which uses three-dimensional printing to create a porous formulation...that disintegrates rapidly...