Product Approval Summaries

BIOLOGICS

FDA has approved the composition of Protein Sciences Corp.’s Flublok influenza vaccine for the 2015-16 flu season. The company says there are two strain changes this year.

DEVICES

FDA has cleared a Cardiovascular Systems 510(k) for its ViperWire Advance Peripheral Guide Wire with Flex Tip for use with peripheral orbital atherectomy systems. “The new guide wire provides physicians with improved flexibility, navigation and ease-of-use—particularly in hard-to-reach, tortuous vessels — when treating arterial calcium associated with peripheral artery disease,” the company says.

Lexmark Healthcare has received FDA 510(k) clearance for the Lexmark NilRead, a Web-based, zero-footprint enterprise diagnostic viewer. The device is available in multiple configurations – core, clinical and interpretation – covering different workflows ranging from the distribution of imaging studies and reports within the enterprise to full primary interpretation workflows in decoupled enterprise image management implementations, according to the company. It is intended for use in performing medical imaging studies, including mammography and digital breast tomosynthesis.

FDA has cleared a Rivanna Medical 510(k) for the Accuro, a handheld and untethered smart phone-sized ultrasound device that is designed to guide spinal anesthesia with automated 3D navigation technology. The device is also cleared for ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies.

HUMAN DRUGS

FDA has approved AstraZeneca’s Iressa (gefitinib) for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. The kinase inhibitor blocks proteins that promote the development of cancerous cells with the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations), an agency release says.

B. Braun Medical Inc. has received FDA approval of its 70% dextrose for injection in a 2L flexible container. The company says the product will be used with its Pinnacle TPN Management System and other automated compounding devices.

FDA has granted final ANDA approval to NJ-based IGI Laboratories for its diclofenac sodium 1.5% topical solution, a nonsteroidal anti-inflammatory drug indicated for treating pain from osteoarthritis of the knee.

FDA has approved a Novartis NDA for Entresto (sacubitril/valsartan) tablets for treating heart failure. The drug was reviewed under FDA’s priority review program, and the NDA contained data from more than 8,000 adults. In clinical trials, Entresto was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to enalapril, the agency says in a news release.

FDA has approved an Otsuka Pharmaceutical Co. NDA for Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder.

Vertex Pharmaceuticals has received FDA approval of Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) to treat cystic fibrosis patients age 12 and older who have the F508del mutation that causes the production of an abnormal protein that disrupts how water and chloride are transported in the body. An FDA statement says that having two copies of this mutation—one inherited from each patient—is the leading cause of cystic fibrosis.