Prefilled injection pen for growth hormone
The FDA approved Novo Nordisk's (Princeton, N.J.) Norditropin FlexPro (somatropin [rDNA origin] injection) prefilled injection pen, for use in children and adults with growth hormone disorders. The FlexPro features a user-friendly design that makes it easy to learn and use, and an audible click that confirms the medication has left the pen. The FlexPro requires no reconstitution and no cartridge loading.
Norditropin FlexPro is available in 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL pens. Pens may be left at room temperature for up to 3 weeks without risk of spoilage.
In a study evaluating the usability of the new product, patients found the norditropin FlexPro easy to use; 99% of patients found it easy to push the button to dose and 99% found it easy to inject their dose.
Radiofrequency for severe asthma
The FDA recently approved the first medical device to use radiofrequency energy to treat severe and persistent asthma in certain adults.
The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta-agonist medications.
The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.
The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device. Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.
Digital IVUS catheter more convenient
Volcano Corporation (San Diego, Calif.) has received FDA approval to market the Eagle Eye Platinum digital intravascular ultrasound (IVUS) catheter, a state-of-the-art catheter that offers all of the benefits of the predecessor Eagle Eye Gold catheter, plus improved deliverability and the convenience of additional radiopaque markers. According to the company, the Eagle Eye Platinum's radiopaque markers should provide a quick and easy way for practitioners to estimate lengths without the need for a separate pullback device. These markers, along with deliverability improvements, will allow for more precision and accuracy in treating blood vessel occlusions.
The new catheter is the third generation of catheters in the Eagle Eye line.
FDA clears automated immunoassay FOBT
Polymedco, Inc. (Cortlandt Manor, N.Y.) has received FDA clearance for the company's OC-Sensor Diana, a high-throughput, automated system for the immunoassay fecal occult blood test (iFOBT) used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps, and colitis.
The new test measures 280 samples per hour and ensures that quality data is consistently collected. Its compact design, only 24.8 inches by 22 inches by 22 inches and weighing 133 pounds, is ideal for workstation setup.
The iFOBT system provides increased sensitivity and specificity over traditional screening methods. Personal-use iFOBT packs allow the patient to easily collect a sample and return it to the lab for quick and accurate results. The iFOBT requires no dietary or medicinal restrictions and only a single sample collection.
Generic version of Loprox shampoo available
Perrigo Company (Allegan, Mich.) was granted final approval to manufacture and market ciclopirox shampoo 1%, a generic version of Loprox shampoo. Shipments are scheduled to start immediately. The antifungal shampoo is indicated for the treatment of seborrheic dermatitis of the scalp in adults.