Product Approval Summaries

DEVICES

FDA has approved a Boston Scientific PMA for the Innova Vascular Self-Expanding Stent System, a treatment for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. The device comprises a Nitinol self-expanding bare metal stent with an advanced delivery system, and is available in a range of sizes, from 5 mm to 8 mm and lengths of 20 mm to 200 mm, the company says. It features a “hybrid cell architecture” with open-cells along the stent body and closed cells at each end for uniform and accurate deployment, it says.

FDA has cleared a 510(k) for the use of Dentca’s new 3D printable material as a denture base. The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates, which will eventually replace traditional heat-cured and auto polymerizing conventional denture making methods, the company says. “By improving the manufacturing process with the help of precise 3D printers, we will be making the denture production process quicker, more accurate and more predictable,” it says. The dental prosthetics printer uses a computer-aided design and manufacturing software system, specialized tray impression systems, and a digital denture file database.

GE Healthcare has received FDA 510(k) clearance for a low-dose computed tomography (CT) lung cancer screening option for its CT scanners. “Physicians using low dose CT for lung cancer screening will now have access to the benefits from a screening indication, including GE Healthcare’s new low-dose screening reference protocols,” the company says. The protocols are tailored to the CT system, patient size, and the most current recommendations from a wide range of professional medical and governmental organizations, it says. GE says that all new 64-slice and greater CT scanners, and almost all of its 16-slice CT scanners are qualified systems and will include the screening option. The new protocols are able to utilize technologies such as ASiR, ASiR-V and Veo, which are designed to reduce image noise, it adds.

FDA has cleared an Ortho Clinical Diagnostics 510(k) for the Ortho Vision Analyzer, an interactive, automated analyzer for transfusion medicine laboratories. Designed with secure monitoring technologies for safety checks and balances, the device is intended to give transfusion medicine professionals the ability to track critical steps in the immunohematology testing process, the company says. It uses proprietary Intellicheck Technology to verify and document diagnostic checks throughout the testing process. Also, the device’s e-Connectivity Technology provides 24/7 remote data tracking to monitor instrument performance while maximizing uptime, the company says.

Tyber Medical has received FDA 510(k) clearance for the TyWedge Opening Osteotomy Wedge System, a titanium plasma-sprayed PEEK wedge implant, intended for use for fusion with the use of allograft or autograft for an osteotomy correction. The device comes in two configurations with a total of 15 footprints — the Evans TyWedge with nine foot prints and the Cotton TyWedge with six foot prints. It also features radiographic markers for intraoperative visualization and simple instrumentation for precise implant placement, the company says.

HUMAN DRUGS

FDA has granted final approval to Aurobindo Pharma for  two generic drugs: omeprazole delayed-release capsules in 10 mg, 20mg and 40mg dosages to treat gastroesophageal reflux disease, a generic version of AstraZeneca’s Prilosec and the anti-osteoporosis ibandronate sodium injection, 3mg/3ml dosage, a generic version Hoffmann-La Roche’s Boniva injection.

Lupin has received from FDA final approval for its fenofibrate tablets 54 mg and 160 mg , a generic version of Teva’s fenofibrate tablets, 54 mg and 160 mg, indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia.

Novartis has received FDA approval of a supplemental NDA for Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – who have chronic immune thrombocytopenic purpura (ITP). The drug can be used in this patient population when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen, an agency release says.

FDA has approved an expanded use for Raptor Pharmaceutical Corp.’s Procysbi (cysteamine bitartrate) delayed-release capsules to treat children two to six years of age with nephropathic cystinosis. The drug was previously approved for treating adult and pediatric patients aged six years and older.

Sprout Pharmaceutical has received FDA approval of Addyi (flibanserin) with a boxed warning to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women.