Regulatory and Drug Approvals News

Novartis announced that Afinitor(R) (everolimus) tablets has been approved by the US Food and Drug Administration (FDA) for patients with advanced renal cell carcinoma (RCC) after failure of treatment with Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

The US Food and Drug Administration (FDA) announced on Monday that it had approved Afinitor oral tables (everolimus) for the treatment of advanced kidney cancer in patients where the disease continued to progress after treatment with other drugs. Afinitor is manufactured by Novartis International AG of Basel, Switzerland.

Inverness Medical Innovations, Inc. (NYSE: IMA), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, announced that it will begin marketing and distributing the new C. DIFF QUIK CHEK COMPLETE(TM) rapid test as an in vitro diagnostic aid for Clostridium difficile associated disease (CDAD).

VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), announced the FDA Ophthalmic Devices Advisory Panel unanimously recommended that the FDA approve, with conditions, the premarket application (PMA) for its implantable telescope for End-Stage AMD.

The US Food and Drug Administration (FDA) alerted consumers on Monday that together with the California Department of Public Health (CDPH), they are investigating Salmonella contamination in pistachio products made at a Californian plant and that the producer is voluntarily recalling about 1 million pounds of pistachio products.

Cambridge Consultants has released its latest Dry Powder Inhaler (DPI) generic specification to address recent regulatory requirements and technological developments, helping speed up the development process and time to market for inhalation devices.

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in surgical cardiac ablation, announced that its new innovative disposable cryoablation system, Cryo1, received 510(k) clearance from the Food and Drug Administration, or FDA, for the cryosurgical treatment of cardiac arrhythmias. Additionally, the first patient was successfully treated using the Cryo1 system by Dr.

Physio-Control, Inc., a wholly owned subsidiary of Medtronic, Inc., (NYSE: MDT) announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the LIFEPAK 15 monitor/defibrillator within the United States. Official notification of the FDA 510(k) Premarket Notification was posted to the FDA website on March 16, 2009, and can be viewed here.

Transdermal delivery of estrogen therapy available by prescription "seems not to alter" the risk of venous thromboembolism (VTE), or blood clotting, in postmenopausal patients when compared to oral delivery, a new study suggests.

SNM and the International Partnership for Critical Markers of Disease (CMOD) are co-hosting an in-depth meeting on Friday, May 1, 2009, examining FDA requirements for manufacturing positron emission tomography (PET) radiopharmaceuticals. The meeting, which takes place at the Natcher Auditorium, National Institutes of Health, Bethesda, Md., is scheduled to begin at 6:10 p.m.