Copyright 2009 Medical News Today Latest Regulatory Affairs / Drug Approvals News From Medical News Today. http://www.medicalnewstoday.com/sections/regulatoryaffairs/ admin@medicalnewstoday.com (MNT Admin) editors@medicalnewstoday.com (MNT Editors) en-us Sat, 07 Nov 2009 01:00:00 PST http://www.medicalnewstoday.com/articles/170202.php http://www.medicalnewstoday.com/articles/170202.php Novartis announced that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland. Swine Flu Fri, 06 Nov 2009 16:00:00 PST http://www.medicalnewstoday.com/articles/170146.php http://www.medicalnewstoday.com/articles/170146.php Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response. Lymphoma / Leukemia / Myeloma Fri, 06 Nov 2009 15:00:00 PST http://www.medicalnewstoday.com/articles/170144.php http://www.medicalnewstoday.com/articles/170144.php Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling update for REYATAZ® to include long-term data from the CASTLE Study. The CASTLE Study assessed a once-daily REYATAZ/ritonavir (REYATAZ/r)-based regimen versus a twice-daily lopinavir/ritonavir (LPV/r)-based regimen in previously untreated adult patients infected with HIV-1. HIV / AIDS Fri, 06 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/170086.php http://www.medicalnewstoday.com/articles/170086.php Federal Drug Administration Commissioner Margaret A. Hamburg announced a new "Safe Use" program for drugs on Wednesday. The program sets out "to reduce the misuse of medications, saying that at least 50,000 hospitalizations a year could be prevented if physicians, pharmacists, patients and parents used greater care in dispensing and taking drugs," Regulatory Affairs / Drug Approvals Fri, 06 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/170104.php http://www.medicalnewstoday.com/articles/170104.php The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Over the past several years, the FDA has found Sexual Health / STDs Fri, 06 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/170106.php http://www.medicalnewstoday.com/articles/170106.php A joint public meeting focused on improving the system for tracing of food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers was announced today by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). Nutrition / Diet Fri, 06 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/170109.php http://www.medicalnewstoday.com/articles/170109.php The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif. Infectious Diseases / Bacteria / Viruses Fri, 06 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/170058.php http://www.medicalnewstoday.com/articles/170058.php Kellogg , the global cereal and convenience food producer based in Battle Creek, Michigan, USA, has announced it is going to stop putting claims on its US packets of Rice Krispies that say the cereal supports children's immunity. According to a statement released on Tuesday, Kellogg said that last year it started adding antioxidants to Rice Krispies cereals as one way to respond to "parents indicating their desire for more positive nutrition in kids' cereal". Nutrition / Diet Fri, 06 Nov 2009 02:00:00 PST http://www.medicalnewstoday.com/articles/170044.php http://www.medicalnewstoday.com/articles/170044.php ARKRAY, Inc., the world's 5th largest manufacturer of diabetes self-monitoring systems, announced that it has received 510(k) clearance from the US Food and Drug Administration for its new GLUCOCARD Vital blood glucose monitoring system. Diabetes Fri, 06 Nov 2009 02:00:00 PST http://www.medicalnewstoday.com/articles/170045.php http://www.medicalnewstoday.com/articles/170045.php Regent ACP, Custom Spine's anterior cervical plate system, has received 510k Clearance from the U.S. Food and Drug Administration (FDA). This product clearance marks the latest addition to Custom Spine's continually expanding product line. Regent ACP is a low profile anterior cervical plate system that was designed with innovative self-locking slides to give the surgeon confidence of the plate being securely locked into place. Bones / Orthopaedics Fri, 06 Nov 2009 02:00:00 PST http://www.medicalnewstoday.com/articles/170046.php http://www.medicalnewstoday.com/articles/170046.php Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Lymphoma / Leukemia / Myeloma Thu, 05 Nov 2009 01:00:00 PST http://www.medicalnewstoday.com/articles/169888.php http://www.medicalnewstoday.com/articles/169888.php The U.S. Food and Drug Administration announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. "Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries," said FDA Commissioner Margaret A. Hamburg, M.D. Pharma Industry / Biotech Industry Wed, 04 Nov 2009 21:00:00 PST http://www.medicalnewstoday.com/articles/169852.php http://www.medicalnewstoday.com/articles/169852.php Canadian physicians can now treat patients suffering from life-threatening aneurysms in one of the body's largest arteries with an endovascular graft delivered during a minimally invasive procedure without blocking a critical artery. Vascular Wed, 04 Nov 2009 19:00:00 PST http://www.medicalnewstoday.com/articles/169849.php http://www.medicalnewstoday.com/articles/169849.php Absorption Systems LP announced that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the U.S. Food and Drug Administration (FDA) to continue development of the company's CellPort Technologies™ testing platform. This unique assay platform enables more specific prediction of potential drug-drug interactions mediated by human drug transport proteins. Pharma Industry / Biotech Industry Wed, 04 Nov 2009 18:00:00 PST http://www.medicalnewstoday.com/articles/169848.php http://www.medicalnewstoday.com/articles/169848.php Catalent Pharma Solutions, one of the leading advanced drug delivery technology providers to the pharmaceutical industry, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Metozolv™ ODT (orally disintegrating tablets) metoclopramide HCL utilizing Catalent's Zydis® fast dissolve technology. Metozolv™ ODT was developed by Wilmington Pharmaceuticals and licensed to Salix Pharmaceuticals. Acid Reflux / GERD Tue, 03 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/169611.php http://www.medicalnewstoday.com/articles/169611.php The U.S. Food and Drug Administration published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). Swine Flu Tue, 03 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/169614.php http://www.medicalnewstoday.com/articles/169614.php The U.S. Food and Drug Administration and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) have sent a team of seafood specialists to Bangladesh this week to help train local officials on aquaculture safety and quality control techniques. The goal of the trip is to work with Bangladeshi officials to help the country improve the overall quality and safety of its aquaculture products for both domestic and international markets. Nutrition / Diet Mon, 02 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/169503.php http://www.medicalnewstoday.com/articles/169503.php Covidien (NYSE: COV), a leading global provider of healthcare products, announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII). Covidien's product is a generic alternative to the branded ACTIQ®. It is a solid formulation of fentanyl that resembles a lozenge on a handle. Cancer / Oncology Mon, 02 Nov 2009 04:00:00 PST http://www.medicalnewstoday.com/articles/169508.php http://www.medicalnewstoday.com/articles/169508.php Mentor Capital, Inc. (Pink Sheets: MNTR) is well poised to be a significant participant in the expanding medical sector of Cancer Immunotherapy with a $5 price objective according to Senior Securities Analyst Howard N. Stillman. That implied 165% gain over the current $1. Breast Cancer Mon, 02 Nov 2009 02:00:00 PST http://www.medicalnewstoday.com/articles/169458.php http://www.medicalnewstoday.com/articles/169458.php To further protect patients from adulterated medicines, the U.S. Pharmacopeial Convention (USP) has announced revised standards for four ingredients widely used in prescription and over-the-counter drugs. The standards, posted on the USP Web site, include new tests for identifying two harmful and potentially deadly contaminants in the four pharmaceutical excipients - inactive ingredients common in medicines for purposes including sweetening agents and solvents. Pharma Industry / Biotech Industry Sun, 01 Nov 2009 03:00:00 PST http://www.medicalnewstoday.com/articles/169415.php http://www.medicalnewstoday.com/articles/169415.php The U.S. Department of Health and Human Services (HHS) issued an interim final rule with request for comments today to strengthen its enforcement of the rules promulgated under the Health Insurance Portability and Accountability Act (HIPAA). Public Health Sun, 01 Nov 2009 00:00:00 PST http://www.medicalnewstoday.com/articles/169374.php http://www.medicalnewstoday.com/articles/169374.php The U.S. Food and Drug Administration sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient. Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. Flu / Cold / SARS Sat, 31 Oct 2009 02:00:00 PST http://www.medicalnewstoday.com/articles/169396.php http://www.medicalnewstoday.com/articles/169396.php Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Diabetes Sat, 31 Oct 2009 01:00:00 PST http://www.medicalnewstoday.com/articles/169386.php http://www.medicalnewstoday.com/articles/169386.php Schering-Plough Corp. (NYSE: SGP) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy. Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PEGINTRON melanoma filing. Melanoma / Skin Cancer Fri, 30 Oct 2009 13:00:00 PST http://www.medicalnewstoday.com/articles/169333.php http://www.medicalnewstoday.com/articles/169333.php The European Medicines Agency has been formally notified by AstraZeneca of its decision to withdraw its application for a centralised marketing authorisation for the medicine Zactima (vandetinib), 100 mg film-coated tablets. Zactima was expected to be used in combination with chemotherapy, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior anticancer therapy. Lung Cancer