Product Approval Summaries

DEVICES

Bracco Diagnostics has received FDA approval for Lumason for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients. The company says it is the first to receive approval for this clinical use of ultrasound contrast both in adults and children.

CardioFocus has received FDA PMA approval for its HeartLight Endoscopic Ablation System for treating patients with paroxysmal atrial fibrillation.

FDA has cleared a Medtronic 510(k) for its PillCam COLON 2 capsule for an expanded indication — detecting colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal origin. The device was originally cleared to visualize the colon for evaluating polyps in patients who are at major risks for colonoscopy or moderate sedation. The capsule endoscope is to be taken orally, and does not require sedation, anesthesia or radiation. The capsule technology may also “limit the risk of complications that could occur from a standard colonoscopy, such as colon perforation, bleeding or cardio-pulmonary complications,” the company says.

Tenex Health Inc. has obtained FDA 510 (k) clearance for its new TX2 MicroTip to treat tendinosis of the shoulder and hip, two areas that were more difficult to reach using the original TX1 MicroTip due to its length.

FDA has cleared an Xtant Medical Holdings 510(k) for the Xspan Laminoplasty Fixation System and its use in the lower cervical and upper thoracic spine (C3-T3). Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord, according to the company. “Unlike a laminectomy, where the entire lamina is removed, only an opening or window is made on one side of the lamina to alleviate the compression of the spinal cord,” it says. “The lamina is then restructured by a small plate which allows the spinal canal to increase in size without losing stability or movement in the vertebrae. This procedure can be completed at single or multiple levels.”

HUMAN DRUGS

FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Stiolto Respimat (tiotropium bromide and olodaterol) that adds to the label data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD). Approval is based on data from the OTEMTO 1 and 2 clinical studies, which showed a clinically meaningful improvement in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ) that evaluatied symptoms, activities, and the disease’s impact on daily life.

FDA has approved a supplemental NDA for Danco Laboratories’ abortifacient Mifeprex (mifepristone) to relax label requirements for administering the drug. The approval expands on-label usage to 70 days after a woman’s last menstrual period. Previously, the label recommended the drug be used within 49 days of the last period. It also cuts the recommended number of doctor visits for the procedure from three to two. And the supplement reduced the dosage for the drug from 600 milligrams to 200 milligrams.

Jazz Pharmaceuticals has received FDA approval for Defitelio (defibrotide sodium) for treating adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome , with renal or pulmonary dysfunction following HSCT.1.

Lannett Company has received approvals from FDA for 2 ANDAs for potassium chloride extended-release capsules USP, 8 mEq and 10 mEq, the therapeutic equivalent to the reference listed drug of Actavis Labs FL and for temozolomide capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to Merck’s Temodar capsules.