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FDA Approves First 3D Printed Prescription Medication

Epilepsy drug Spritam may be one of many custom-made medicines to come that will use the technology

TUESDAY, Aug. 4, 2015 (HealthDay News) — The age of three-dimensional (3D) printing has come to the drug industry, with the U.S. Food and Drug Administration on Monday approving the first pill made with the technology.

The agency approved the prescription drug Spritam (levetiracetam) as a 3D-printed pill, to be taken with other medicines for seizures in certain children and adults with epilepsy.

According to a news release from Ohio-based Aprecia Pharmaceuticals, the drug is made using a 3D printing method called ZipDose Technology, which produces a porous pill that rapidly disintegrates with a sip of liquid. 3D printing has already been used to make medical devices, but Spritam is the first 3D-printed drug to be approved for sale in the United States. It is expected to be available early next year.

In clinical trials of Spritam, the most common side effects included sleepiness, weakness, dizziness, and infection. In children, other common side effects included tiredness, aggressive behavior, nasal congestion, irritability, and decreased appetite.

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