FDA Office of Criminal Investigations director George Karavetsos will step away from the agency to take up a position at a private law firm, according to an internal announcement. Karavetsos drew fire last year for allegedly forcing members of the criminal investigations office to pursue mislabeled foreign-imported injectable drug cases at the expense of issues […]
Food & Drug Administration (FDA)
Ocular Therapeutix touts data from phase III trial of Dextenza
Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days. The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: […]
FDA accepts Allergan’s new drug application for Liletta contraception device
Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed […]
Allergan wins FDA nod for Natrelle Inspira SoftTouch breast implant
Allergan (NYSE:AGN) said today it won FDA approval for its Natrelle Inspira SoftTouch breast implants designed for breast reconstruction, augmentation or revision surgeries. The newly cleared Inspira SoftTouch implant is designed from a new medium firmness gel, the company said, bringing the total number of firmness options or its Natrelle line up to 3. “I am excited […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. Get the full story at our sister site, Drug Delivery […]
FDA rejects Amphastar subsidiary’s Primatene Mist asthma inhaler
Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler. The complete response letter from the federal watchdog told Armstrong Pharmaceuticals that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company conduct […]
FDA warns batteries in medical carts associated with fires, explosions
The FDA issued a warning today to healthcare professionals regarding the safety hazards associated with battery-powered mobile medical carts. The federal watchdog said it has received numerous reports of hospital fires and explosions due to overheated equipment. Mobile medical carts, such as crash carts and medication dispensing carts, usually use high capacity lithium or lead […]
Biogen, Ionis win FDA approval for first spinal muscular atrophy drug
Biogen (NSDQ:BIIB) said last week that it won FDA approval for its spinal muscular atrophy treatment, Spinraza. The drug is the 1st treatment approved in the U.S. for spinal muscular atrophy, a progressive and often fatal genetic disease that causes muscle weakness in infants and toddlers. The FDA previously granted Biogen’s application fast track designation […]
Precision Spine wins FDA 510(k) for AccuFit lateral plate system
Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability. The Parsippany, N.J.-based company’s AccuFit lateral plate system consists of non-sterile, single use rigid plates designed to attach to the lateral portions of the vertebral body of the thoracolumbar spine with bone screws. “As a system that […]
Nephros wins 510(k) for HydraGuard bacterial water filter
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its water ionizer review designed for water bacterial filtration. The River Edge, N.J.-based company said its HydraGuard 10″ UltraFilter is designed to provide 6 months of bacterial protection and filtration for potable water sources such as endoscope re-processors, surgical humidifiers and ice machines. “The HydraGuard is a […]
Stryker’s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II. Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA. The federal watchdog reviewed the order, and said that on September 2 it issued an order […]