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FDA approves first 3-D printed drug

WASHINGTON — The Food and Drug Administration has approved the first prescription drug made through 3-D printing: a dissolvable tablet that treats seizures. Aprecia Pharmaceuticals said Monday the FDA approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The tablet is manufactured through a layered process via 3-D printing and dissolves when taken with liquid. The Ohio-based company says its printing system can package potent drug doses of up to 1,000 milligrams into individual tablets. It expects to launch Spritam in the first quarter of 2016. The FDA has previously approved medical devices — including prosthetics — made with 3-D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process. Aprecia said in a statement it plans to develop other medications using its 3-D platform in coming years, including more neurological drugs. The company is privately owned. Doctors are increasingly turning to 3-D printing to create customized implants for patients with rare conditions and injuries, including children who cannot be treated with adult-size devices. The FDA held a workshop last year for medical manufacturers interested in the technology.  
nypost.com
about 6 years ago
Www.bmj
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The danger in the next big thing

What is the next big thing? How do we know it when we see it? Is it the burger flipping robot that creates 360 different varieties of burger? What would such burgers taste like? It might be the 3D printing technology that is heralded as part of a new industrial revolution (doi:10.1136/bmj.g2963). Our picture of the week, inevitably rendered in glorious two dimensions, is a plastic skull created with 3D printing and used in an operation in a Dutch hospital. However, this plastic skull is not to be confused with helmets that don’t seem to work in the treatment of infant skull deformities (doi:10.1136/bmj.g2741, doi:10.1136/bmj.g2906).  
feeds.bmj.com
about 6 years ago
Www.bmj
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How might 3D printing affect clinical practice?

If a picture is worth a thousand words, the value of a three-dimensional printout could be considerable. 3D printing is starting to disrupt the manufacturing industry, from jewellery to firearms, rapid prototyping to motor racing components. Inevitably, it has now reached healthcare.1 Last year Craig Gerrand, consultant orthopaedic surgeon at Newcastle upon Tyne Hospitals NHS Trust, used computed tomography guided 3D printing to develop a titanium pelvis for a patient with chondrosarcoma.2 And doctors at University of Michigan’s Mott Children’s Hospital have implanted 3D printed plastic splints into the trachea of neonates to rectify tracheobronchomalacia.3  
feeds.bmj.com
about 6 years ago