A Complaint and Consent Decree of Permanent Injunction were filed Wednesday, August 8 in the U.S. District Court for the Northern District of Iowa, Western Division, against Ysselstein Dairy Inc., Rock Valley, Iowa, and its owner and president, Sjerp W. Ysselstein, after illegal drug residues were found in the dairy's cows. The permanent injunction will not become effective against Ysselstein Dairy until the Court signs and enters the Consent Decree. The action follows FDA investigations into the dairy and its practices.

The FDA is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health. The FDA approves new animal drugs with requirements, including a specified time period to withdraw an animal from treatment prior to slaughter, to assure that a drug has been depleted from edible tissue to a level safe for humans.

Ysselstein Dairy produces milk for human consumption and sells dairy cows for slaughter for human consumption. The injunction is based on nine illegal residues in the edible tissue of seven dairy cows sampled by the U.S. Department of Agriculture's Food Safety Inspection Service (FSIS) between July 21, 1992, and March 10, 2006. The drug residues found by FSIS included antibiotics such as tetracycline, sulfadimethoxine, flunixin, oxytetracycline, and penicillin at levels not permitted by the FDA.

Under the terms of the Consent Decree, the dairy and Ysselstein must implement systems for identifying animals, keeping records, drug control, drug accountability, and drug residue withdrawal control. Furthermore, if the FDA informs the defendants of their not being in compliance with the terms of the Decree or the Federal Food, Drug, and Cosmetic Act, the FDA may require them to cease operations until they are in compliance. The Decree also provides for the dairy and Ysselstein to pay a fine for each day they fail to comply with the Decree and for each animal that they sell or deliver for sale in violation of the Decree.

FDA's Kansas City District Office conducted the investigations that led to the Consent Decree. FDA's Center for Veterinary Medicine Division of Compliance, FDA's Office of the Chief Counsel, and the U.S. Attorney's Office in the Northern District of Iowa processed and filed the case.

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, today granted tentative approval for nevirapine tablets, indicated for use with other antiretroviral agents for the treatment of HIV-1 infection, and for the pediatric triple fixed dose combination tablet of lamivudine, stavudine and nevirapine -- the first fixed dose anti-HIV product designed to treat children under the age of 12 years. These two drugs mark the 50th and 51st AIDS drugs approved or tentatively approved for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

The fixed dose combination comprises a complete HIV regimen that is taken twice daily and can be used once patients have tolerated 14 days of lead-in treatment with nevirapine taken once daily. The tablet combination can also be dissolved in water for children who cannot swallow tablets. The fact that all three drugs are combined in one tablet and that this tablet can be stored, distributed, and administered easily to children is a significant advance in the treatment of children infected with HIV in PEPFAR countries.

"The 50th and 51st approvals by the FDA of essential anti-HIV products under the President's Emergency Plan for AIDS Relief bolsters the commitment made by President Bush to ensure the rapid delivery of unprecedented amounts of safe, effective, and quality drugs, at a lower cost, to help those most in need," said HHS Secretary Mike Leavitt in marking the milestone.

Today's approvals under the PEPFAR process are part of the President's five-year, $15 billion effort to fight the HIV/AIDS pandemic around the world – the largest commitment ever by a single nation toward an international health initiative. As of March 31, 2007, PEPFAR supported life-saving antiretroviral treatment for over 1.1 million men, women and children in the Emergency Plan's 15 focus countries in sub-Saharan Africa, Asia and the Caribbean.

Nevirapine tablets, and the triple fixed dose combination of lamivudine, stavudine and nevirapine, and 46 other drugs are "tentatively approved" generic drugs (or drug combinations) that have been evaluated by the FDA as part of the PEPFAR program, but which are not available for sale in the United States because of existing patent protection or other U.S. marketing protections. Three other drugs evaluated by FDA as part of this program have been approved for marketing in the United States because they do not have any existing patent or other U.S. marketing protections.

FDA's tentative approval means that, although existing patents and/or marketing exclusivity prevent the approval for sales of the product in the United States, the product meets all of FDA's manufacturing quality and clinical safety and efficacy requirements - thus helping to ensure that AIDS patients abroad who receive these medications get the same quality of medications as Americans.

All 51 of the drugs can be purchased outside the United States by PEPFAR partners using U.S. taxpayer dollars.

HHS and FDA are part of a multi-agency effort led by the Office of the Global AIDS Coordinator to accomplish PEPFAR's initial five-year goals of supporting treatment for 2 million HIV-infected people, prevention of 7 million new infections, and care for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children. On May 30, President Bush announced his intention to work with Congress to reauthorize PEPFAR for five additional years.

"Support for antiretroviral treatment is more than just drugs – it is a sign of hope," said Ambassador Mark Dybul, the U.S. Global AIDS Coordinator. "It reflects the idea that President Bush has stated so well -- that where you live should not determine if you live or die from HIV/AIDS."

In 2004, FDA implemented an expedited PEPFAR application review process for individual antiretroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The process includes an FDA commitment to work closely with manufacturers before they submit a marketing application to the FDA, especially those who have never previously submitted marketing applications, and to conduct a priority assessment of those applications.

"The FDA has helped save lives by making these much-needed, high-quality, generic drugs for AIDS available for patients in countries served by PEPFAR," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "In addition, our goal is to assure that drugs purchased by PEPFAR meet the same safety, efficacy, and manufacturing standards as drugs used in the United States."

PEPFAR remains committed to funding the purchase of the lowest-cost ARVs, whether they are innovator or generic drugs, as long as the medications have been demonstrated to be safe, effective, and of high quality. PEPFAR purchases also must be consistent with international law.

As part of the PEPFAR initiative, FDA is collaborating with the World Health Organization's Prequalification Program (WHO/PQ). As a result of this collaboration, FDA approved or tentatively approved antiretroviral drugs are placed on the WHO Prequalification Program. This is a program many countries with developing economies use to guide their purchasing of drug products from specific manufacturers so that they can be assured they are purchasing quality medicinal products.

"The countries of the world that depend on the WHO Prequalification Programme to help them purchase quality products have benefited immensely by this cooperation between the FDA and the WHO," said Dr. Howard Zucker, WHO Assistant Director General for Health and Pharmaceuticals. "Assuring the quality of products like this one made especially for children in developing economies is a major cornerstone of our battle against the HIV epidemic and of our effort to help assure children have access to quality medicines."

In addition, HHS and FDA continue to work to strengthen the knowledge and training of in-country, national drug regulatory authorities in the PEPFAR focus countries, alone and in collaboration with each other, so that they can better ensure the quality of the medical products available to their citizens.

For more information on PEPFAR, visit www.pepfar.gov.

To see a consumer article called Improving Access to HIV/AIDS Drugs Abroad, visit http://www.fda.gov/consumer/updates/pepfar081307.html

FDA Approves Updated Warfarin (Coumadin) Prescribing Information
New Genetic Information May Help Providers Improve Initial Dosing Estimates of the Anticoagulant for Individual Patients
The U.S. Food and Drug Administration announced today the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug.

Manufacturers of warfarin, the generic version of Coumadin, are to add similar information to their products' labeling, FDA said.

The labeling change highlights the opportunity for healthcare providers to use genetic tests to improve their initial estimate of what is a reasonable warfarin dose for individual patients. Testing may help optimize the use of warfarin and lower the risk of bleeding complications from the drug.

These labeling updates are based on an analysis of recent studies that found people respond to the drug differently based, in part, on whether they have variations of certain genes.

FDA estimates that 2 million persons start taking warfarin in the United States every year to prevent blood clots, heart attacks and stroke. Warfarin is a difficult drug to use because the optimal dose varies and depends on many risk factors including a patient's diet, age, and the use of other medications.

Patients who take a dose larger than they can tolerate are at risk of life-threatening bleeding. Those who receive too low a dose are at risk of equally dangerous blood clots. Dosing is particularly important at the beginning of therapy, when problems in adjusting the dose can lead to complications such as bleeding.

Warfarin is the second most common drug – after insulin –implicated in emergency room visits for adverse drug events.

Physicians and other health care professionals who prescribe warfarin regularly check to see if the drug is working properly by ordering a test called the PT or prothrombin time that evaluates the blood's ability to clot properly. The results are measured in seconds and compared with the expected value in healthy people, known as the International Normalized Ratio or INR.

"Today's approved labeling change is one step in our commitment to personalized medicine. By using modern science to get the right drug in the right dose for the right patient, FDA will further enhance the safety and effectiveness of the medicines Americans depend on," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D.

The FDA's "personalized medicine" initiative makes use of pharmacogenomics—the science that predicts a response to drugs based upon a person's genetic makeup. This effort supports the personalized health program spearheaded by Health and Human Services Secretary Mike Leavitt.

A person's genes "encode" enzymes and differences in the sequence of a gene can cause differences in enzyme activity or sensitivity. That is why different people process the same drug differently.

One-third of patients receiving warfarin metabolize it quite differently than expected. Research has shown that some of the unexpected response to warfarin depends on a patient's variants of the genes CYP2C9 and VKORC1.

"Although genetic testing can currently identify who has these genetic variants, more studies are needed to explore the precise starting dose for these patients," said Larry Lesko, Ph.D., director of the FDA's Office of Clinical Pharmacology. "FDA has been working with other government agencies and organizations to develop such studies under the auspices of our three-year-old Critical Path Initiative, which addresses the challenges of moving promising medical products from discovery to patient use."

FDA's Critical Path Initiative has funded a research project with the University of Utah and the Critical Path Institute of Tucson, Ariz., to develop genetically based instructions for warfarin dosing. The Initiative has also facilitated meetings and planning with the National Heart, Lung and Blood Institute for a clinical trial that will study warfarin dosing based on genetic test information and is helping to pay for another clinical study being conducted by Harvard Partners that will derive personalized warfarin dosing algorithms for patients new to the drug.

The dosage and administration of warfarin must be individualized for each patient according to the particular patient's PT/INR response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.

Bristol-Myers Squibb Co. of Princeton, N.J., is the manufacturer of Coumadin.

For more information see New Labeling Information for Warfarin.

FDA Warning on Codeine Use by Nursing Mothers
May Increase Chance of Serious Side Effects in Infants
The U.S. Food and Drug Administration (FDA) is concerned that nursing infants may be at increased risk of morphine overdose if their mothers are taking codeine and are ultra-rapid metabolizers of codeine. The agency has reviewed all available information on this subject since a medical journal reported the death of a 13-day old breastfed infant who died from morphine overdose. The morphine levels in the mother's milk were abnormally high after taking small doses of codeine to treat episiotomy pain. A genetic test showed that the mother was an ultra-rapid metabolizer of codeine.

"Our best advice to physicians prescribing codeine-containing products to nursing mothers is to prescribe the lowest dose needed for the shortest amount of time," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research. "And nursing mothers should always consult their physicians before taking any codeine containing products."

Codeine is an ingredient found in prescription and non-prescription medicines that are used to relieve pain or treat cough. Once in the body, some of the codeine is converted (metabolized) to morphine. Some people, due to their genetic makeup, metabolize codeine much faster and more completely than others. These people, called ultra-rapid metabolizers, are more likely to have higher-than-normal levels of morphine in their blood after taking codeine. Mothers who are ultra-rapid metabolizers may have higher-than-usual levels of morphine in breast milk.

According to the FDA, nursing mothers have used codeine safely for many years. In medical practice, codeine is generally considered the safest choice among narcotic pain relievers for nursing women and their babies. However, to raise awareness of this possible health risk and to prevent morphine overdose in nursing infants, FDA is requiring manufacturers of prescription codeine medicines to include information about codeine ultra-rapid metabolism in drug package insert information. In addition, FDA has posted information about this issue on the FDA website for healthcare providers and patients.

Nursing mothers taking codeine (or other narcotic pain relievers) should know how to watch for signs of overdose in their babies. Breast fed babies normally nurse every two to three hours and should not sleep for more than four hours at a time. Signs of morphine overdose in a nursing baby include increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.

The chance of being an ultra-rapid metabolizer varies among different population groups from less than 1 per 100 people to 28 per 100 people. For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known. The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There is a FDA-cleared test to check for ultra-rapid metabolism, but there is only limited information about using this test for codeine metabolism. At this time, the test result alone may not correctly predict if a mother's breast milk will have too much morphine if she uses codeine to treat pain. This test cannot substitute for a doctor's judgment.

Mothers and babies gain many health benefits from breastfeeding. When a nursing mother must take medicine, her infant may be exposed to some risks from that medicine. It is important for healthcare professionals and nursing women using codeine or other medicines to discuss these risks and benefits.

For more information, go to Use of Codeine Products in Nursing Mothers.

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The U.S. Food and Drug Administration today approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17. This is the first FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups.

Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up.

“The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.”

The FDA first approved Risperdal in 1993 for the treatment of schizophrenia in adults. The drug later was approved for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and the treatment of irritability associated with autistic disorder in children and adolescents 5 to 16 years old.

Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.

The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.

Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.

Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.

For more information:

FDA Office of Pediatric Therapeutics
www.fda.gov/oc/opt/default.htm

National Institute of Mental Health—Schizophrenia
www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm

National Institute of Mental Health—Bipolar Disorder
www.nimh.nih.gov/healthinformation/bipolarmenu.cfm

FDA Proposes New Rule for Sunscreen Products
Highlights Include New UVA Rating System, Sun Warning Information
The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens using only sunburn protection factor or SPF values," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "Under today's proposal, consumers will also now know the level of UVA protection in sunscreens, which will help them make informed decisions about protecting themselves and their children against the harmful effects of the sun."

Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can not. There are two types of UV light, UVA and UVB. UVA light is responsible for tanning and UVB for sunburn. Both can damage the skin and increase the risk of skin cancer.

The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. The FDA proposal provides a ratings system for UVA sunscreen products on a scale of one to four stars. One star would represent low UVA protection, two stars would represent medium protection, three stars would represent high protection, and four stars would represent the highest UVA protection available in an OTC sunscreen product. If a sunscreen product does not provide at least a low level (one star) of protection, FDA is proposing to require that the product bear a "no UVA protection" marking on the front label near the SPF value.

Ratings would be derived from two tests the FDA proposes to assess the effectiveness of sunscreens in providing protection against UVA light. The first test measures a product's ability to reduce the amount of UVA radiation that passes through it. The second test measures a product's ability to prevent tanning. This test is nearly identical to the SPF test used to determine the effectiveness of UVB sunscreen products.

In addition, a "Warnings" statement in the "Drug Facts" box will be required of all sunscreen product manufacturers. The warning will say: "UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen." The warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

"Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens," said Douglas Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research. "The labeling being proposed today strengthens the existing labeling for sunscreens by educating consumers on the added importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen."

When finalized, the proposed regulation would amend the existing OTC sunscreen rule published in 1999 that established regulations related to UVB light and mandated that OTC UVB sunscreen products be labeled with a SPF. FDA also is amending its existing 1999 rule to increase the SPF from SPF30+ to SPF50+. Previously, FDA had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF2 to SPF50+. SPF50 provides more UVB protection than lower SPF values. Additionally, the proposed rule:

revises the existing SPF (UVB) testing procedures;
allows new combinations of active ingredients; and
asks for comments on the issue of nanoparticles.
FDA is accepting comments on the new rule for 90 days until November 26, 2007. Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments

FDA Expands Warning on Eating Raw Oysters from
Hood Canal in Washington State
Additional Growing Area Linked to Illness Outbreaks
The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an additional part (growing area 5) of the southern tip of Hood Canal in Washington state due to a foodborne illness outbreak caused by Vibrio parahaemolyticus bacteria.  This follows an earlier outbreak and August 10 warning about oysters harvested from growing area 6 of Hood Canal.

Symptoms of the illness, vibriosis, include watery diarrhea, often with abdominal cramping, nausea, vomiting, fever, and chills. Usually these symptoms occur within 24 hours of ingestion and last no more than three days. Severe disease is rare and occurs most commonly in people with weakened immune systems. Those who believe they have experienced these symptoms after consuming raw oysters should consult their health care provider and contact their local health department.

Raw oysters harvested from growing area 5 in Hood Canal from July 31 through August 20, 2007 have caused at least six people to become ill in Washington state. To date, records indicate that raw oysters from the area were distributed to California, Colorado, Idaho, New York, Oregon, Utah, Washington state, and British Columbia (Canada).

The Washington State Department of Health has closed the growing area associated with the illness and has asked commercial oyster harvesters and dealers who obtained oysters from this area to recall them.

Consumers who have recently purchased oysters should check with the place of purchase and ask if they were harvested from the affected growing areas. The recall involves both shucked oysters and oyster in the shell (shell stock oysters).

Those with weakened immune systems, including people affected by HIV/AIDS, chronic alcohol abuse, liver, stomach, or blood disorders, cancer, diabetes, or kidney disease, should avoid eating raw oysters, regardless of where they are harvested.

FDA advises that consumers can continue to enjoy oysters in many cooked preparations by doing the following:

At Restaurants and other Foodservice Establishments:

Order oysters fully cooked.
In the Shell:

Purchase oysters with the shells closed
Throw away any oysters with shells already opened.
Never allow raw seafood to come into contact with cooked food.
Boil or steam the oysters:
Boil oysters until the shells open. Once shells open, boil for an additional three to five minutes.
To steam—add oysters to water that is already steaming and cook live oysters until the shells open, once open steam for another four to nine minutes.
Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time,
Discard any oysters that do not open during cooking.
Shucked Oysters:

Never allow raw seafood to come into contact with cooked food.
Cook the oysters in one of the following ways:
Boil or simmer shucked oysters for at least three minutes or until the edges curl. \
Fry at 375° F for at least three minutes.
Broil three inches from heat for three minutes.
Bake at 450° F for 10 minutes.
For more information:
Hood canal oyster area closed — second closure due to illness outbreak
www.doh.wa.gov/Publicat/2007_news/07-143.htm


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FDA Approves Human Thrombin for Topical Use in Surgery
The U.S. Food and Drug Administration approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

Evithrom is the first human thrombin approved since 1954 and is the only product currently licensed. It is derived from human plasma obtained from carefully screened and tested U.S. donors and has undergone steps to further reduce the risk for transfusion-transmitted diseases.

Evithrom is indicated as an aid to stop oozing and minor bleeding from capillaries and small veins and when control of bleeding by standard surgical techniques is ineffective or impractical. The product is applied to the surface of bleeding tissue and may be used in conjunction with an absorbable gelatin sponge. Evithrom must not be injected into blood vessels, which would result in serious clinical complications and may even be fatal.

"The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma."

In a clinical trial involving several hundred subjects, Evithrom was found comparable to cattle-derived thrombin in both safety and effectiveness.

Evithrom is manufactured by Omrix Biopharmaceuticals, Ltd., Ramat Gan, Israel, and will be distributed by Johnson & Johnson Wound Management, a division of Ethicon, Inc., Somerville, N.J.

The U.S. Food and Drug Administration today announced approval of a second test for the detection of West Nile virus (WNV) in blood and organs.

The cobas TaqScreen WNV test is an automated test that's able to detect the genetic material of the virus itself early in the infection. Such nucleic acid testing improves blood and organ safety, detecting whether donated blood and organs have been infected even before the donor's body has begun to produce antibodies against the virus.

Most often, WNV is transmitted to humans by mosquitoes. But WNV can also be transmitted by blood transfusion or organ transplantation from infected donors. While WNV infection is common in Africa, Asia, and the Middle East, it did not appear in the United States until 1999. Since then, WNV has become endemic in most of this country, with from 1 million to 3 million cases between 1999 and 2006, according to the Centers for Disease Control and Prevention.

"This action is the culmination of the dedicated efforts of FDA, our sister agencies, blood establishments, and manufacturers to bring donor screening tests to market for this increasingly common virus," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "As a result, blood centers and hospitals now have a choice of two FDA approved tests to screen for West Nile Virus in donated blood and organs."

Most people infected with WNV show no signs of the disease but about 1 in 150 to 1 in 350 infected people will develop serious symptoms, including encephalitis, an inflammation of the brain. Since the introduction of the virus, the reported number of human cases of serious WNV in the United States has grown steadily from 62 in 1999 to 4,269 in 2006.

WNV has been especially virulent this year. Although it is still early in the WNV season, 58 blood donors who are possibly positive for the virus have been reported to the CDC as of August 21, 2007.

The cobas TaqScreen WNV test is approved for the detection of the virus in plasma specimens from human donors of whole blood and blood components (plasma, red or white cells, platelets) and living donors of cells, reproductive cells and other tissues. It is also intended for use in testing plasma specimens of organ donors when specimens are obtained while the donor's heart is still beating. The test is not intended for use on samples of cord blood or as an aid in the diagnosis of WNV infection.

Approval comes as FDA is preparing guidance on the use of licensed WNV screening tests for blood donors.

The test is manufactured by Roche Molecular Systems Inc. of Pleasanton, Calif.

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The U.S. Food and Drug Administration today approved Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly, a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain.

"This type of therapy provides an alternative for patients who have not responded to other therapies," said Steven Galson, M.D., M.P.H., director, Center for Drug Evaluation and Research. "The new approval reflects FDA's goals for making effective and safe treatments available to patients with rare diseases under the Orphan Drugs program."

FDA has approved Somatuline Depot for the long-term treatment of patients with acromegaly who have had inadequate response to or can not be treated with surgery and/or radiation therapy. This new treatment lowers the levels of certain hormones in the body, including GH and insulin-like growth factor. Excessive GH secretion, working through insulin-like growth factor, can cause enlargement of the hands, feet, facial bones, and enlargement of internal organs such as the heart and liver. If untreated, patients with acromegaly often have a shortened life span because of heart and respiratory diseases, diabetes mellitus, and colon cancer.

The safety and effectiveness of Somatuline Depot (administered through injection) was determined in two pivotal clinical trials involving a total of 400 patients. Common side effects include diarrhea, gallstones, skin reactions such as itching, slow heart rate, and change in blood sugar levels. Patients with diabetes who receive treatment with Somatuline Depot may need to have their diabetes medication adjusted.

FDA designated Somatuline Depot orphan status because the drug treats a rare disease and meets other criteria. Orphan products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product. Acromegaly affects approximately 15,000 people in the United States and Canada and is most commonly found in middle-aged adults. Patients with acromegaly have reduction in life expectancy of 5 to 10 years.

The drug will be marketed by Beaufour Ipsen, Paris, France.