Latest US Food and Drug Administration Stories
Dietary supplements accounted for more than half the Class 1 drugs recalled by the US Food and Drug Administration Dietary supplements accounted for more than half the Class 1 drugs recalled by the U.S. Food and Drug Administration from 2004-12, meaning they contained substances that could cause serious health problems or even death, a new study from St. Michael's Hospital has found. The majority of those recalled supplements were bodybuilding, weight loss or sexual enhancement products...
LONDON and SOUTH SAN FRANCISCO, Calif., April 17, 2013 /PRNewswire/ -- GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO(TM) ELLIPTA(TM) as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with...
AGAWAM, Mass., April 16, 2013 /PRNewswire/ -- In anticipation of new US Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection. Titled, "Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA," it is available to download at...
Lee Rannals for redOrbit.com – Your Universe Online An environmental group has leveled a lawsuit against a group of baby food makers aimed at forcing the companies to put warning labels on products sold in California. Gerber Products, Del Monte Foods, Beech-Nut Nutrition and other baby foods and juices are being sued by the Environmental Law Foundation (ELF) for selling products that contain lead at levels that require warning labels under California Proposition 65. However, lawyers...
Lawrence LeBlond for redOrbit.com - Your Universe Online A new report is adding weight to growing evidence that energy drinks are bad news for your health. A US Food and Drug Administration (FDA) probe has been opened into energy drink makers after several deaths have been blamed on caffeine overload from these popular beverages, and one company – Monster Beverage – has been the center of attention since the death of a 14-year-old Maryland girl in December 2011. The reported...
NEW YORK, February 28, 2013 /PRNewswire/ -- Today, Investors Alliance announced new research reports highlighting Endo Health Solutions Inc (NASDAQ: ENDP), Actavis Inc (NYSE: ACT), Mylan Inc. (NASDAQ: MYL), Elan Corporation, plc (NYSE: ELN) and Amgen, Inc. (NASDAQ: AMGN). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below. Endo Health Solutions Inc Research Report...
redOrbit Staff & Wire Reports - Your Universe Online Two pharmaceutical companies have issued a recall of their anemia drug Omontys after receiving reports that some kidney dialysis patients had suffered severe allergic reactions after taking the medication. According to the Associated Press (AP), California-based Affymax Inc. and Illinois-based Takeda Pharmaceutical Co. said some of the more than 25,000 patients who had received the drug had experienced adverse effects afterwards,...
VILLEPINTE, France, Feb. 14, 2013 /PRNewswire/ -- Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem® (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older. The Committee voted 10 to 6 (with one member abstaining)...
RALEIGH, N.C., Feb. 13, 2013 /PRNewswire-iReach/ -- Scioderm announced that the US Food and Drug Administration (FDA) has reviewed and allowed the investigational new drug (IND) application for SD-101 to proceed. SD-101 is a topical treatment being developed for the treatment of Epidermolysis Bullosa (EB). The Company plans to initiate a Phase 1 study in the coming months, with initiation of the Phase 2B/3 study in EB patients to occur in the second half of 2013. EB is a rare...
PALO ALTO, Calif., Jan. 22, 2013 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) announced the completion of an End of Phase 2 meeting with the US Food and Drug Administration (FDA). Preliminary agreement was reached regarding the design of a Phase 3 placebo-controlled randomized registration trial of Telintra (ezatiostat) for the treatment of Low to Intermediate-1 risk myelodysplastic syndrome (MDS), using red-blood-cell transfusion independence as the endpoint. In accordance with the...
