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The First 3D-Printed Prescription Drug from Aprecia Pharmaceuticals Receives FDA Approval

by Vishnuprasad on  August 4, 2015 at 4:40 PM Drug News   - G J E 4
The first prescription drug made through 3D printing, a dissolvable tablet that treats seizures, has received the US Food and Drug Administration's approval.
The First 3D-Printed Prescription Drug from Aprecia Pharmaceuticals Receives FDA Approval
The First 3D-Printed Prescription Drug from Aprecia Pharmaceuticals Receives FDA Approval
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Aprecia Pharmaceuticals said the regulatory authority approved its drug Spritam for adults and children who suffer from certain types of seizures caused by epilepsy. The company manufactured the tablet with a layered process via 3D printing.

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The drug dissolves when it takes with liquid. The company's 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 3D printing. An agency spokeswoman confirmed the new drug is the first prescription tablet approved that uses the process.

The company officials said in a statement it plans to develop other medications using its 3D platform in coming years, including more neurological drugs.

Doctors are increasingly turning to 3D printing to develop 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.



Source: Medindia
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