The analyzer uses nuclear magnetic resonance spectroscopic detection to identify and quantify lipoprotein concentrations. LipoScience, Inc., an in vitro diagnostic company committed to advancing patient care in cardiovascular, metabolic and other diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera® Clinical Analyzer.
The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Hospira Inc. said Tuesday it received a warning letter from the Food and Drug Administration based on a recent inspection of a medical device manufacturing facility in Costa Rica.
The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.
United Health Products, Inc. which develops and markets products and technologies in the healthcare sector, today announced that its hemostatic gauze which is registered and branded in the USA under the trademark Hemostyp™ has received 510K approval from the FDA under the application and registration of its manufacturing agent. Hemostyp was originally introduced into the market in 2002 as a Class I exempt product for external wound care and dental applications.
An unscheduled inspection of an aseptic manufacturing process can hit a pharmaceutical company with the fury of a New England nor'easter. But a new management brief explains how a best-practice control and monitoring system can minimize the danger of FDA noncompliance. The brief is available for download from Microtest Laboratories.
The US Food and Drug Administration (FDA) has approved Afinitor (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole.
Fitch Ratings expects the Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 as compared to 2011 while the industry faces several ongoing operational risks, according to a new report.