Friday March 22, 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 Proposes to Curb Sales of Flavoured E-cigarettes to Teenagers

The health regulator also proposed pre-market applications for all flavoured e-cigarette products that continue to be sold by August 8, 2021

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e-cigarette, vaping
In this April 11, 2018, photo, an unidentified 15-year-old high school student uses a vaping device near the school's campus in Cambridge, Mass. Health and education officials across the country are raising alarms over wide underage use of e-cigarettes and other vaping products. The devices heat liquid into an inhalable vapor that's sold in sugary flavors like mango and mint — and often with the addictive drug nicotine. VOA

The US Food and Drug Administration (FDA) has proposed to curb sales of flavoured e-cigarettes to teenagers.

The health regulator on Wednesday said that it is proposing to end all flavoured electronic nicotine delivery system (ENDS) products such as electronic cigarettes, except tobacco, mint and menthol-flavoured products.

According to the Centers for Disease Control and Prevention, a total of 3.6 million middle and high school students reported using e-cigarettes last year.

“Evidence shows that youth are especially attracted to flavoured e-cigarette products, and that minors are able to access these products from both brick-and-mortar retailers, as well as online, despite federal restrictions on sales to anyone under 18,” FDA Commissioner Scott Gottlieb, said in a statement.

“With these concerns in mind, today, we’re advancing our policies aimed at preventing youth access to, and appeal of, flavoured e-cigarettes and cigars.”

E-cigarettes, Smokers
Talia Eisenberg, co-founder of the Henley Vaporium, uses her vaping device in New York, Feb. 20, 2014. VOA

The new proposed policy also subjects all manufacturers and retailers to FDA enforcement for selling certain flavoured ENDS products without authorisation.

The FDA had previously threatened to ban most flavoured e-cigarettes in 2017 but did not take any enforcement moves.

However, with the new policy, FDA intends to prioritise its enforcement to focus on protecting youth from becoming addicted to nicotine.

Also Read- Eating Mushrooms May Prevent Cognitive Decline in Older Adults

It believes, at the same time, “that ENDS products still hold promise to help transition currently addicted adult smokers to potentially less harmful sources of nicotine”, Gottlieb said.

The health regulator also proposed pre-market applications for all flavoured e-cigarette products that continue to be sold by August 8, 2021. (IANS)