dijous, 16 de juliol del 2015

Novo Nordisk wins FDA nod for FlexPro PenMate

Novo Nordisk wins FDA nod for FlexPro PenMateNovo Nordisk said it won FDA premarket approval for its FlexPro PenMate designed for use with the company’s Norditropin FlexPro pens.

The device is designed for users who prefer needles be hidden during injection of the human-growth hormone used to treat a number of growth issues, the Denmark-based company said.

The PenMate is a cylindrical attachemnt that conceals the needles during insertion, and provides  a large gripping surface so patients can hold the pen firmly during the process.

“Children and adolescents with growth hormone-related disorders are the primary users of Norditropin, and some feel uneasy at the thought of having to inject their medicine. FlexPro PenMate was developed to hide the needle, demonstrating our commitment to keeping the patient at the center of everything we do,” biopharmaceutical senior veep Eddie Williams said in a press release.

Novo Nordisk said they expect the PenMate to be available in the U.S. during the latter half of this year.

Last August, Novo Nordisk won FDA 510(k) clearance for its kid-friendly NovoPen Echo insulin injection pen. The company touted the pen as the 1st insulin pen to combine half-unit dosing with a memory log to help patients keep track of injection dose and time.

The post Novo Nordisk wins FDA nod for FlexPro PenMate appeared first on MassDevice.



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