FDA News Digest…   Search Tools…   News Search | Generic Drug Companies | Google Health & Pharma | Company Name | API | Pharma Stocks | News - Archive October 10, 2008 __________________ FDA Licenses for Marketing New Therapy for Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease. Attacks can produce rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. Swelling of the larynx can lead to asphyxiation. FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. BPH is a male disease wherein the prostate gland – located between the bladder, which stores urine, and the urethra, the tube through which urine exits the body – enlarges in men as they age. By age 50, roughly 50 percent of all men suffer from BPH. By age 80, that number jumps to 75 percent. FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table. Food industry management will use the FIRST tool kit as part of ongoing employee food defense training programs. The tool kit focuses on five key points that industry and businesses can use to educate first line workers about the risks of food contamination. It also provides industry with measures to consider and implement to reduce these risks. Each of the letters in the FIRST acronym describes an action that a first line employee can take to mitigate risks of contamination. FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia. Hemophilia A is a rare, hereditary, bleeding disorder in which a protein needed to form blood clots, factor VIII, is missing or its level is reduced. The disorder affects about 15,000 individuals in the United States, nearly all of whom are male. "Administering Kogenate FS to children with hemophilia A on a daily basis before a bleeding event occurs will reduce bleeding into joints and help prevent joint damage, a major cause of disability in hemophiliacs," said Jesse Goodman, M.D., M.P.H., director, FDA’s Center for Biologics Evaluation and Research. October 8, 2008 __________________ FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products. The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children. October 7, 2008 __________________ FDA Approves Use of Temporary Pump to Assist Heart's Right Side The U.S. Food and Drug Administration today approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. "This collaboration with the PATH-MVI supports the overall mission of the FDA and specifically the Agency's work under our Critical Path Initiative," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. "We are actively seeking ways to help organizations such as PATH develop safe and effective products that can benefit the public health both in the United States and globally." October 6, 2008 __________________ FDA Detects Melamine Contamination in Flavored Drink The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA’s on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. October 3, 2008 __________________ FDA Issues Interim Safety and Risk Assessment of Melamine and Melamine-related Compounds in Food The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula. A safety/risk assessment is a scientifically based methodology used to estimate the risk to human health from exposure to specified compounds. It is based on available data and certain scientific assumptions in the absence of data. The purpose of the FDA interim safety/risk assessment was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. The interim safety/risk assessment evaluated the melamine exposure in infant formula and in other foods. October 1, 2008 __________________ HHS Announces New Steps in Anthrax Preparedness HHS Secretary Mike Leavitt today announced two new actions in the department’s ongoing activities to bolster the nation’s preparedness for a potential outdoor anthrax attack. In development since March of this year, the steps being implemented today build upon more than a decade of preparedness efforts across HHS and other agencies of the federal government. The first of today’s actions focuses on United States Postal Service letter carriers who volunteer to deliver medicines directly to residences in their communities during an emergency. September 30, 2008 __________________ FDA Awards $5.2 Million in Grants to Further Food and Feed Safety The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies. "These cooperative agreements support and enhance local food protection efforts consistent with our Food Protection Plan," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The grants represent an important step in the FDA’s continued efforts to integrate and improve the effectiveness of food safety systems at the federal, state and local levels." FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years. The contract is the cornerstone of the FDA’s Information Technology for the 21st Century (ICT21) bioinformatics initiative, an extensive IT modernization program encompassing data management, data warehousing, IT infrastructure and IT security. "This contract sets the stage for the FDA to have IT to acquire, analyze and act on data critical for import protection, food protection and medical product safety plans," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "We are creating a high-tech, efficient, data management system designed to meet the needs of those who must accomplish our mission -- protecting and promoting the health of the American public." September 29, 2008 __________________ FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease" A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety. The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo. Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age. September 26, 2008 __________________ FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products are being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. September 23, 2008 __________________ FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses. Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company. September 20, 2008 __________________ FDA Updates Health Information Advisory on Melamine Contamination On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China. September 18, 2008 __________________ FDA Proposes Label Requirements for Refused Imported Foods The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk. "This system will make it more difficult for food importers to evade import controls after being denied admission into the United States," said Randall Lutter, Ph.D., deputy commissioner for policy. "It will complement our ongoing efforts to monitor food imports." FDA Issues Draft Guidance on Regulating Genetically Engineered Animals The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. September 12, 2008 __________________ FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined. “There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.” The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11. FDA Approves Treatment for Rare Neurologic Disease The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. The FDA designated Gamunex as an orphan drug to treat CIDP. The orphan drug designation provides manufacturers with financial incentives to develop treatments for rare diseases, those affecting fewer than 200,000 people in the United States. "This approval is part of the FDA's effort to address unmet medical needs in patients who are suffering from rare and serious diseases," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. The FDA is advising caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States as mentioned below. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status. September 11, 2008 __________________ FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case The U.S. Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her from introducing animals into the food supply until the FDA had approved her record-keeping system. The FDA initiated the case after illegal levels of drug residue were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold for use as human food. On July 30, 2008, U.S. District Court Judge Joseph R. Goodwin sentenced Rhodes, finding her guilty of criminal and civil contempt for introducing adulterated food into the marketplace and for failing to maintain proper medication records for calves as part of her business, Rhodes Livestock. The violations occurred over a number of years, as recently as 2008, and involved 23 positive tests for drugs such as neomycin, penicillin, gentamicin and other antibiotics. No repercussions to human health were reported. September 5, 2008 __________________ FDA to Post Quarterly Report of Potential Safety Issues The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue. September 4, 2008 __________________ FDA Approves DNA Test to Measure Hepatitis B Virus Levels The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient’s blood. Assessing a patient’s viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections. The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing. FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died. The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. “This new software modification will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health, FDA. “While the software doesn't fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.” August 27, 2008 __________________ FDA Clears Test to Help Doctors Manage Heart Transplant Patients The U.S. Food and Drug Administration today announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection. "AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing post-operative heart transplant rejection," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "It is an example of how advancements in science and technology are leading to new medical care diagnostics." AlloMap measures genetic information contained in the white blood cells (cells of the immune system that defend the body against invading viruses, bacteria or other foreign material) from a patient's blood sample. August 22, 2008 __________________ FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low number of platelets, the blood components that help with clotting. In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often unable to compensate for this loss. "This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. August 15, 2008 __________________ FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. Azaspiracid toxins are odorless, tasteless, and cannot be destroyed or neutralized by freezing or cooking, including boiling. Individuals who have experienced gastrointestinal symptoms such as those noted above after eating any of the products listed below should consult their health care professional. Symptoms typically occur within hours of consumption and persist for two to three days. FDA Approves First Drug for Treatment of Chorea in Huntington's Disease The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington’s disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntington’s disease. Currently there are no other drugs that are FDA-approved to treat chorea. Serious side effects reported with use of Xenazine include depression and suicidal thoughts and actions. Xenazine should not be used in patients who are actively suicidal or in patients with untreated depression. Concerns about the risk of suicide are heightened in all patients with Huntington’s disease. “Xenazine represents hope for patients and families dealing with this difficult disease,” said Timothy Coté, M.D., M.P.H., director of FDA’s Office of Orphan Products Development. “For the first time, there is a treatment that can help patients with this disease gain some quality of life.” Huntington's disease is a rare, inherited neurological disorder affecting about 1 in 10,000 people August 8, 2008 __________________ FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. August 5, 2008 __________________ FDA Approves 2008-2009 Flu Vaccines The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. Approval information and specific indications can be found at http://www.fda.gov/cber/flu/flu2008.htm. August 4, 2008 __________________ FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. The FDA announced the availability of the guidance documents in today's Federal Register; copies of all of the guidances are available on FDA’s website. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days. July 31, 2008 __________________ FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors. July 30, 2008 __________________ FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Tamaulipas, Mexico (business address is in Nuevo Leon, Mexico) contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. As a result, until further notice, the FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.   View Earlier News   © 2008 Betterchem.com