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The FDA is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. This action is part of the FDA's continued commitment to help consumers make informed and healthy food choices, and responds to a health claim petition submitted by the Beverage Institute For Health & Wellness for The Coca-Cola Co.
The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act of 1990 for the relationship between calcium intake and osteoporosis. The proposal would amend the existing claim by
The FDA recently learned that two patients who were treated with Rituxan (rituximab) for systemic lupus erythematosus (SLE) developed progressive multifocal leukoencephalopathy (PML), a fatal viral infection of the central nervous system. This side effect has been reported in patients as late as 12 months after their last dose of Rituxan.
SLE is not an approved indication for Rituxan. The drug is approved only for the treatment of people with non-Hodgkin's lymphoma and people with rheumatoid arthritis whose disease no longer responds to other common treatments. Rituxan acts on the body's immune system by decreasing certain types of white blood cells. This factor makes the drug effective in treating lymphoma and rheumatoid arthritis, but it also increases the body's susceptibility to infection. The Rituxan label was updated in February 2006 to include postmarketing reports of cases of serious viral illnesses, including PML, in patients with lymphoma who received Rituxan.
People who take, or who have taken, Rituxan should promptly call their doctor if they experience confusion or any major changes in vision, balance, or coordination. Health care professionals should report serious adverse events possibly associated with Rituxan to the FDA's MedWatch Program by telephone at (800) 332-1088, by fax at (800) 332-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or at www.fda.gov/medwatch/, the MedWatch Web site.
Rituxan is manufactured by Genentech, Inc. of South San Francisco.
In January 2007, the FDA approved a new formulation of FluMist, MedImmune's influenza virus vaccine live, intranasal. The new formulation of the vaccine is a liquid, which health care providers can conveniently store in a refrigerator, in contrast to the original formulation, which required storage in a freezer. FluMist is licensed for preventing influenza in healthy children and adults from ages 5 years to age 49 years.
In December 2006, the FDA approved Celebrex (celecoxib) for a new use—relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients ages 2 years and older. Celebrex, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), was originally approved in l998 for rheumatoid arthritis and osteoarthritis in adults.
JRA is an autoimmune disease that affects 30,000 to 60,000 children in the United States. The disease is associated with joint swelling, pain, decreased range of motion, and abnormalities of growth and development. In some cases, systemic complications may occur including uveitis, a chronic inflammation of the eye. In severe, uncontrolled cases, permanent disability may occur because of progressive joint damage.
A 24-week study of Celebrex involving 242 patients ages 2 years to 17 years demonstrated its effectiveness in treating JRA. The most commonly reported side effects were cough, cold, upper respiratory tract infection, abdominal pain, headache, fever, nausea, diarrhea, and vomiting.
Celebrex has not been studied in patients younger than 2 years, in patients who weigh less than 22 pounds, or in patients showing signs of having "systemic onset JRA," a more serious type of JRA associated with high fever and rash. Celebrex should be used with caution in patients with systemic onset JRA because of the risk for serious adverse reactions, including abnormal clotting tests, which can be associated with disseminated intravascular coagulation (DIC). DIC is a serious condition in which the body's blood-clotting mechanisms are activated throughout the body instead of being localized to an area of injury.
Safety and efficacy were not studied beyond six months, and experience with adults suggests the possibility of longer-term cardiovascular problems. As part of the approval of Celebrex, the drug's manufacturer has agreed to conduct two Phase 4 postmarketing studies: a short-term controlled trial to evaluate high blood pressure, and a several-year registry study to further evaluate long-term safety issues, including renal toxicity, high blood pressure, and cardiovascular events.
Celebrex is manufactured by New York-based Pfizer Inc.
The FDA has approved a prescription drug for the management of obesity in dogs. Slentrol reduces appetite and fat absorption to produce weight loss. A veterinarian will need to determine whether the dog should be treated, based on the dog's weight and general health.
"Veterinarians are well aware that overweight pets are at a higher risk of developing various health problems, from cardiovascular conditions to diabetes to joint problems," says Stephen Sundlof, D.V.M., Ph.D., director of the FDA's Center for Veterinary Medicine.
Veterinarians generally define a dog that weighs 20 percent more than its ideal weight as obese. Surveys have found that approximately 5 percent of dogs in the United States are obese, and another 20 percent to 30 percent are overweight.
Slentrol is a new chemical entity that blocks the assembly and release of lipoproteins into the bloodstream. The mechanism for producing weight loss is not completely understood, but seems to result from reduced fat absorption and a feeling of fullness (satiety) signal from lipid-filled cells lining the intestine.
The dog is given an initial dose for the first 14 days. After that, the veterinarian will assess the dog's progress at monthly intervals, adjusting the dose depending on the dog's weight loss. After the dog has achieved the goal weight, the drug's manufacturer recommends continued use of the drug during a three-month period while the veterinarian and dog owner establish the optimal level of food intake and physical activity needed to maintain the dog's weight.
Side effects associated with Slentrol include vomiting, loose stools, diarrhea, lethargy, and loss of appetite.
To discourage human use, the label of Slentrol includes the warning: "Not for use in humans. Keep this and all drugs out of reach of children." The label also cites adverse reactions associated with human use, including abdominal distention, abdominal pain, diarrhea, flatulence, headache, nausea, and vomiting.
Slentrol is manufactured by New York-based Pfizer Inc.
The FDA has approved the first generic version of Wellbutrin XL (bupropion hydrochloride) extended-release tablets. This drug is indicated for the treatment of major depressive disorder (MDD).
The approval, in December 2006, is an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, Wellbutrin XL was the 21st highest-selling brand-name drug in the United States, with sales totaling more than $1.3 billion, according to the online magazine Drug Topics.
The FDA received a formal request for FDA action (citizen petition) that asked the agency to consider several issues for Bupropion Hydrochloride Extended-Release Tablets, including how similarly the drug is absorbed into the bloodstream. After reviewing the issues raised in the petition, the FDA determined that its standards for approval of the generic drug application for bupropion are appropriate.
Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand-name drug and is its equal in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.
Bupropion Hydrochloride Extended-Release Tablets, 150 milligrams and 300 milligrams, are manufactured by Anchen Pharmaceuticals Inc. of Irvine, Calif.
In November 2006, the FDA expanded the approved use of Herceptin (trastuzumab), a biological cancer drug. This new indication is for Herceptin, in combination with other cancer drugs, as treatment of HER2 positive breast cancer after lumpectomy or mastectomy surgeries.
Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, the FDA approved Herceptin to treat breast cancer that has spread to other sites in the body (metastatic). This latest approval expands use of Herceptin to women who have cancer in the breast and regional lymph nodes that have been surgically removed. Herceptin should be prescribed only for women diagnosed with HER2 positive breast cancer.
"This is especially good news for women who have breast cancer caused by excessive amounts of the HER2 protein because this cancer typically has a poor prognosis," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. The FDA granted priority review to the supplemental application for Herceptin.
The two studies leading to this new approved indication were conducted by the National Cancer Institute-sponsored Cooperative Groups, a multicenter clinical trial effort. Patients in both trials received standard chemotherapy after surgery for breast cancer; about half also were given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005. After positive results, the National Cancer Institute, part of the National Institutes of Health, ended the studies early.
The results showed that women who received Herceptin combined with chemotherapy had fewer relapses up to three years after surgery. The estimated three-year disease-free rates were 87 percent in women receiving Herceptin and chemotherapy and 75 percent in those receiving chemotherapy alone. It is too early to know whether Herceptin combined with chemotherapy will increase the cure rate or lower the risk of death from breast cancer.
The most serious side effect of Herceptin is heart failure that requires medical treatment. Because of the risk of heart disease, only certain patients should receive the drug, including
Less common but serious side effects include infusion reactions (chills, fever,
or shortness of breath) that rarely are accompanied by lung problems, low white
blood cell counts, and low red blood cell counts.
Herceptin is manufactured by Genentech Inc., San Francisco.
Colazal (balsalazide disodium) has been approved for the treatment of mildly to moderately active ulcerative colitis in patients ages 5 years to 17 years. This type of bowel disease causes chronic inflammation of the colon and rectum, and affects about 5 per 100,000 children in the United States each year.
Pediatric use of Colazal was granted orphan drug status in December 2006 under the FDA's Orphan Drug program. This program provides financial incentives for firms that develop therapies for diseases affecting fewer than 200,000 patients a year.
Colazal had been previously approved for use in adults with mildly to moderately active ulcerative colitis. The drug's safety and effectiveness in children was demonstrated in a multicenter study in 68 patients ages 5 years to 17 years. They were randomly selected to receive either 6.75 grams or 2.25 grams of Colazal a day for a total of eight weeks. In the study, 45 percent of the children on the higher dose, and 37 percent on the lower dose, showed clinical improvement in rectal bleeding and the appearance of the gastrointestinal mucosa.
The most common adverse events associated with the use of Colazal were headache and symptoms related to the gastrointestinal tract, such as abdominal pain, vomiting, and diarrhea. The overall rate of drug-related adverse events was higher in the low-dose group compared with the high-dose group. This result may have been due to the lower efficacy seen in the low-dose group, according to the study.
Colazal is manufactured by Salix Pharmaceuticals Inc., Morrisville, N.C.
Taxotere (docetaxel) injection concentrate has been approved for use in combination with the chemotherapy drugs cisplatin and fluorouracil prior to radiotherapy to treat people who have inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). This disease represents about 3 percent of all new cancer cases in the United States.
The approval "will provide prescribers with a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival," says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research.
Taxotere's approval in October 2006 was based on the results of a study of 358 people with previously untreated, inoperable, locally advanced SCCHN. Study participants were divided into two groups: one received Taxotere in combination with cisplatin and fluorouracil, and the other received only cisplatin and fluorouracil. The participants received chemotherapy prior to radiation therapy. Surgery was allowed after chemotherapy, either before or after radiation therapy.
The participants in the Taxotere arm of the study experienced a longer survival time (18.6 months versus 14.2 months) and a longer time until disease worsening or death (11.4 months versus 8.3 months) than the group on cisplatin and fluorouracil alone.
The most frequent side effects reported during the study by the people on Taxotere were decreases in both white and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea. Compared to participants receiving cisplatin and fluorouracil alone, those on Taxotere had greater hair loss, decreases in white blood cells, fever or infection with low white blood cells, fluid retention, diarrhea, and neurosensory abnormalities.
Taxotere is manufactured by Sanofi-Aventis, Paris.
The FDA has approved the first generic versions of Zofran (ondansetron) injection, injection premixed, tablets, orally disintegrating tablets, and oral solution.
Ondansetron is indicated to prevent nausea and vomiting associated with surgery, radiotherapy, and cancer chemotherapy. Ondansetron Injection and Injection Premixed were approved in November 2006. Ondansetron Tablets, Orally Disintegrating Tablets, and Oral Solution were approved in December 2006.
The approvals are an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, Zofran was the 20th highest-selling brand-name drug in the United States, with sales totaling more then $839 million as reported in the online magazine Drug Topics.
Ondansetron
Injection is manufactured by TEVA Pharmaceuticals USA, North Wales, Pa.
Ondansetron
Injection Premixed is manufactured by SICOR Pharmaceuticals Inc., Irvine, Calif.
Ondansetron
Hydrochloride Tablets are manufactured by Dr. Reddy Laboratories Ltd., Bridgewater,
N.J.
Ondansetron Orally Disintegrating Tablets are manufactured by Kali Laboratories
Inc., Somerset, N.J.
Ondansetron Hydrochloride Oral Solution is manufactured by Roxane Laboratories
Inc., Columbus, Ohio.
Invega (paliperidone) extended-release tablets were approved in December 2006 to treat schizophrenia. Paliperidone is a new molecular entity, meaning that the medication contains an active substance that has never before been approved for marketing in any form in the United States. Paliperidone is the principal active metabolite of risperidone, a drug already marketed for treating schizophrenia.
Schizophrenia is a chronic, disabling mental disorder that affects more than 2 million Americans. Symptoms include hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits, such as difficulty with perception, memory, or abstract thinking.
In three six-week studies of 1,665 adults with schizophrenia, the effectiveness of Invega at relieving symptoms of schizophrenia was found to be superior to an inactive substance (placebo).
Among the commonly reported side effects in the studies were restlessness, movement disorders, rapid heartbeat, and sleepiness. The effectiveness of the drug has not been evaluated in placebo-controlled trials for longer than six weeks, and people who use the drug for extended periods should be periodically reevaluated by a physician.
Invega is manufactured by ALZA Corp. in Mountain View, Calif., for Janssen, L.P., in Titusville, N.J.
The FDA has expanded the use of the nutrient content claim "lean" on labels of foods that are categorized as "mixed dishes not measurable with a cup." A final rule allowing this expansion was published in the Federal Register on Jan. 12, 2007.
The FDA acknowledges that meals-on-the-go have made their way into consumers' diets as a convenient meal option. With controlled nutrient and portion size, these foods serve a useful purpose in assisting consumers in selecting a diet that is consistent with recommended U.S. Dietary Guidelines.
The rule allows the food labels of products such as burritos, pizza rolls, egg rolls, and sandwiches that have less than 8 grams (g) of total fat, 3.5 g or less of saturated fat, and less than 80 milligrams (mg) of cholesterol per reference amount customarily consumed (RACC) (140 g) to bear the nutrient content claim "lean."
Before this FDA rule, the nutrient content claim "lean" applied only to seafood and game meat products and meal and main dish products regulated by the FDA that meet the criteria set forth by the agency for these categories. The U.S. Department of Agriculture (USDA) has defined the nutrient content claim "lean" for meat and poultry products regulated by the USDA, as well.
The FDA has approved Cyanokit, which contains the drug hydroxocobalamin, intravenous tubing, and a sterile spike for reconstituting the drug product with saline, to treat known or suspected cyanide poisoning. The December 2006 approval improves the nation's ability to respond to emergencies, including a potential attack by terrorists.
Cyanokit received a priority review and was approved under the Animal Efficacy Rule, which allows the use of animal data for evidence of a drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans.
The drug was shown to significantly improve the survival of cyanide-poisoned animals in studies. In addition, the safety, metabolism, and excretion of Cyanokit were evaluated in 136 healthy adult humans. At the proposed starting dose of 5 grams, the side effects were mild-to-moderate. The drug exits the body unchanged in the urine. In the presence of cyanide, Cyanokit's active drug takes up the cyanide and becomes a form of vitamin B12.
The most frequently reported side effects in the trial were red urine and skin redness, a temporary increase in blood pressure, headache, nausea, and injection site reactions.
Cyanokit is manufactured for EMD Pharmaceuticals Inc. by Merck Santé SAS in Semoy, France, and is packaged by Dey Laboratories of Napa, Calif.
A first-of-a-kind medical device has been approved to treat babies born with moderate-to-severe hypoxic-ischemic encephalopathy (HIE), a potentially fatal injury to the brain caused by low levels of oxygen. The Olympic Cool-Cap system, approved by the FDA in December 2006, is designed to prevent or reduce damage to the brains of these babies by keeping the head cool while the body is maintained at a slightly below-normal temperature.
"This approval brings new hope to parents of the approximately 5,000 to 9,000 babies each year who are born in the United States with moderate to severe hypoxic-ischemic encephalopathy," says Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "Until now, there has been no effective treatment for these infants other than supportive care. Up to 20 percent of them died, and 25 percent suffered permanent disability because of neurological deficits."
The Olympic Cool-Cap treats the patient by maintaining a steady flow of water at a selected cool temperature through a cap covering the infant's head. The system was found safe and effective in a study of 234 infants with moderate- to-severe HIE. At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group compared with the control group.
The Cool-Cap is manufactured by Olympic Medical Corp., a subsidiary of Natus Medical Inc. of San Carlos, Calif.
The FDA has approved a test to screen blood donors for a blood-borne parasite that causes Chagas' disease, a serious and potentially fatal infection. Approved in December 2006, the ORTHO T. cruzi ELISA Test System detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite and is the first such test approved by the FDA.
"Our blood supply is now extremely safe from diseases once frequently transmitted by blood, such as HIV," says Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. "However, we are constantly faced with new threats."
It is estimated that as many as 11 million people are currently infected by T. cruzi, which is most commonly found in parts of Mexico, and Central and South America. The infection is usually acquired from the bite of an infected insect, but also can be transmitted through blood transfusions or organ transplants. Early infection is usually mild and unrecognized, but is lifelong and may lead to organ damage, particularly of the heart and esophagus. Experts estimate that T. cruzi infection causes an estimated 50,000 deaths annually worldwide.
Concerns about the potential for transfusion- and organ-transmitted Chagas' disease in the United States have heightened because of the increase in the number of U.S. residents who previously lived in countries where the infection is common. This new test identifies infected donors and therefore can reduce the risk of disease transmission through blood transfusion or organ transplantation.
In studies reviewed by the FDA, the test was found to be accurate at least 99 percent of the time.
In addition to screening people who donate whole blood, this test is intended for use in screening plasma and serum samples from organ, cell, and tissue donors. At this time, the test is not approved to diagnose Chagas' disease.
The test is manufactured by Ortho-Clinical Diagnostics Inc., Raritan, N.J.