Product Approval Summaries

BIOLOGICS

FDA has approved a Genentech supplemental BLA for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. Follicular lymphoma is the most common slow-growing non-Hodgkin’s lymphoma (NHL), according to the company, and accounts for about 20% of NHL cases each year.

DEVICES

FDA has cleared an APN Health 510(k) to market Navik 3D, a cardiac mapping system that is designed to reduce the cost and complexity of electrophysiology procedures. The device is intended to give cardiologists real-time 3D catheter location in the heart from 2D fluoroscopic images and correlate them with the electrical activation of the heart to create 3D maps of cardiac chamber of interest in abnormal heart rhythms such as atrial fibrillation, the company says. The system includes a workstation and iPad, and it displays real-time 3D cardiac maps in a number of different formats, including anatomical maps, cardiac electrical activation maps, and cardiac voltage maps.

FDA has approved Boston Scientific’s Acuity X4 Quadripolar Left Ventricular (LV) leads. “The FDA approval of the quadripolar leads, the wires that connect cardiac resynchronization therapy (CRT) devices to the heart, marks the first time the company will offer a full X4 CRT system – both the device and the leads – to the U.S. market,” the company says. The leads are engineered with four electrodes along a “unique 3D shape,” it says, adding that they are designed to “enable physicians to place them in the vasculature easily and to allow pacing at an optimal site to improve the patient response to CRT therapy.”

Teleflex has received FDA 510(k) to market its newly designed Arrow VPS Stylet. The new design features a single, double and triple lumen pre-loaded, pressure injectable Arrow Peripherally Inserted Central Catheter with Chlorag+ard technology for use with its current Arrow Vascular Positioning System (VPS) platform.

HUMAN DRUGS

FDA has approved Allergan’s Aczone (dapsone) gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. According to the company, the gel treats both inflammatory and non-inflammatory acne in a once-a-day application with a new pump delivery system.

Novartis has received FDA approval of Afinitor (everolimus) tablets for treating adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic.

FDA has approved a Pfizer NDA for Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate. Pfizer says Xeljanz XR is the first once-daily oral RA treatment in the Janus kinase inhibitors drug class.

Teligent, Inc. has received approval from FDA for an ANDA for desoximetasone ointment USP 0.25%, the generic equivalent of Taro Pharmaceuticals USA’s Topicort Ointment, 0.25% indicated to treat swelling and itching caused by a variety of skin disorders.