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Novo Nordisk Receives FDA Approval For Norditropin FlexPro

Novo Nordisk has received FDA approval for Norditropin FlexPro (somatropin [rDNA origin] injection), a pre-filled injection pen to be used by children and adults with growth hormone disorders.

Norditropin is used to treat children with growth failure caused by very low or no production of growth hormone and in adults who don’t produce enough growth hormone.

Norditropin is also approved for the treatment of children who have short stature associated with Noonan syndrome, Turner syndrome, and for treatment of children with short stature born small for gestational age with no catch-up growth by age 2-4 years. Patients can receive support and training for Norditropin FlexPro through the NordiCare program.

Novo Nordisk claimed that Norditropin FlexPro has a user friendly design which makes it easy to learn and use, and an audible click that confirms that the medication has left the pen.

Norditropin requires no reconstitution and no loading of cartridges. It is available in 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL pens. After first use, the 5 mg/1.5 mL and 10 mg/1.5 mL pens may be left at room temperature for up to three weeks without risk of spoilage.

Novo Nordisk said that in a study designed to evaluate the usability of the product, 100% of patients found it easy to learn how to use Norditropin FlexPro, while 99% of patients found it easy to push the button to dose and 99% found it easy to inject their dose.

Pinchas Cohen, professor of pediatrics at the David Geffen School of Medicine at UCLA and chief of endocrinology at the Mattel Children’s Hospital at UCLA, said: “Easy to use, growth hormone delivery devices allow patients and health care professionals alike to benefit from the convenience of these pens.”

Eddie Williams, vice president of Biopharmaceuticals at Novo Nordisk, said: “We worked hard to make daily injections with Norditropin FlexPro simple, hoping to help patients achieve their individual treatment goals. This approval may provide the thousands of patients with these growth hormone disorders an easy to use and simple treatment option.”