Novo Nordisk’s FlexPro PenMate Wins FDA Nod

July 17, 2015

Novo Nordisk said Thursday that it has won FDA 510(k) clearance for its FlexPro PenMate for injection of Norditropin FlexPro 5 mg, 10 mg and 15 mg.

The drug injection system is meant for children and adolescents with growth hormone-related disorders, especially those who are uncomfortable with using needles to inject themselves, the Danish company says. The device hides the needle with a cylindrical attachment so users won’t see it when they inject their medicine.

The prefilled injection pen can be stored outside of the refrigerator for up to 21 days after first use, the devicemaker adds.

Novo Nordisk plans a U.S. launch later this year. — Jason Scott