Showing posts with label SPRITAM. Show all posts
Showing posts with label SPRITAM. Show all posts

Wednesday, January 6, 2016

FDA odobrila prvi 3D-Printed lek

Izgleda da smo stvarno ušli u 21 vek.
"Aprecia Pharmaceuticals Company today announced that the U.S. Food and Drug Administration (FDA) has approved 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.1 SPRITAM utilizes Aprecia's proprietary ZipDose® Technology platform, a groundbreaking advance that uses three-dimensional printing (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."
detaljnije ...