Wednesday November 20, 2019

Anti-epilepsy pill manufactured with 3D printer gets US FDA approval

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Washington: The US Food and Drug Administration has approved the sale of an anti-epilepsy pill manufactured with a three-dimensional (3D) printer.

Photo Credit: www.medscape.com
Photo Credit: www.medscape.com

Aprecia Pharmaceuticals announced that the FDA had approved its Spritam medication for the treatment of epilepsy.

The company said that with its ZipDose 3D printing technology, it is possible to create a detailed, porous structure which allows the pill to dissolve faster while delivering up to 1,000 mg of medication in a single dose.

Aprecia’s Spritam, the first manufactured with 3D printing technology to win FDA approval, will reach the market early in 2016.

Three-dimensional printing technology has lowered costs substantially over the past few years, enabling designers and experts in a range of fields to create complex pieces and tools in record time.

The FDA has approved the commercial distribution of several medical and prosthetic devices created by 3D printers.

Aprecia said the ZipDose technology will improve the administration of medications to children and the elderly.

(IANS/EFE)

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FDA Wants Women Getting Breast Implants to Receive Stronger Warnings about Possible Risks and Complications

The recommendations are the agency's latest attempt to manage safety issues with the implants

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FDA, Women, Breast Implants
FILE - A photo shows the U.S. Food & Drug Administration (FDA) campus in Silver Spring, Maryland. VOA

U.S. health officials want women getting breast implants to receive stronger warnings about the possible risks and complications. FDA.

The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients for implants.

The recommendations are the agency’s latest attempt to manage safety issues with the implants.

FDA, Women, Breast Implants
The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients. Pixabay

In recent years, the FDA and regulators elsewhere have grappled with a link between a rare cancer and a type of textured implant, some of which have been recalled. Separately, the agency has received thousands of reports of health problems that some women attribute to the implants, including arthritis, fatigue and muscle pain.

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The FDA will take public comment on the recommendations before adopting them. (VOA)