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Noxafil (posaconazole) has been approved to prevent fungal infections caused by certain molds and yeast-like fungus called Aspergillus and Candida. The FDA approved the drug in September for use in people who have weakened immune systems after bone marrow transplants and for people with decreased white blood cell counts that make it difficult for the body to fight infections after chemotherapy for cancer.
Noxafil is an antifungal drug which contains an active substance that has never before been approved for marketing in any form in the United States.
The safety and effectiveness of Noxafil were evaluated in clinical trials consisting of 1,844 people, ages 13 years to 82 years. In two studies of people who had compromised immunity and were at high risk for invasive fungal infections, those who received Noxafil had comparable or lower rates of invasive Aspergillus and Candida infections than those who received other antifungal medications.
The most common side effects in people receiving Noxafil were nausea, vomiting, diarrhea, rash, a decrease in potassium blood levels and platelet counts, and abnormalities in liver function tests. Rare side effects possibly related to the drug include abnormal heart rhythm (QTc prolongation) and liver function impairment.
Noxafil is manufactured by Schering Corp., Kenilworth, N.J.
Three cases of botulism in Georgia associated with pasteurized carrot juice that may not have been properly refrigerated prompted the FDA in September 2006 to remind consumers of the importance of keeping carrot juice at 40 degrees F or lower. The FDA, the Centers for Disease Control and Prevention (CDC), and health authorities in Georgia continue to investigate the cases.
Inadequate refrigeration of carrot juice allows botulinum spores to multiply to the level at which they can cause illness. Botulism is a rare, serious illness that can cause paralysis. It's caused by botulinum toxin, a nerve poison that under certain conditions is produced by Clostridium botulinum, a bacterium commonly found in soil. Botulism can be fatal and is considered a medical emergency.
Botulinum poisoning can result in the following symptoms: double vision, droopy eyelids, altered voice or trouble with speaking or swallowing, and paralysis on both sides of the body that progresses from the neck down, possibly followed by difficulty in breathing. People experiencing these problems should seek immediate medical attention.
Cold temperatures keep most harmful pathogens from growing and multiplying. Refrigerator temperatures should be no higher than 40 degrees F and freezers no higher than 0 degrees F. Consumers should check the temperatures occasionally with an appliance thermometer. Consumers should look for the words "Keep Refrigerated" or "Refrigerate After Opening" on juice labels to know whether the product should be refrigerated.
Consumers with questions about juice safety also may call (888) SAFEFOOD (723-3366).
The FDA has approved several Abbreviated New Drug Applications (ANDAs) for generic versions of Bayer Corp. Pharmaceutical Division's CIPRO I.V. Injection, a drug to treat certain bacterial infections. The approval, in August 2006, is an important step in the agency's effort to increase the availability of lower-cost generic medications.
Ciprofloxacin Injection, USP, is indicated for the treatment of infections, including urinary tract infections, lower-respiratory tract infections, bone and joint infections, complicated intra-abdominal infections, and skin and skin structure infections.
In 2005, CIPRO I.V. Injection was on the top 200 list of highest-selling brand-name drugs in the United States.
Ciprofloxacin Injection USP, 10 mg/mL (milligrams per milliliter), is packaged in 20 mL and 40 mL vials and a 120 mL pharmacy bulk package. The products are manufactured by multiple generic companies.
The FDA has approved the first fully automated product that combines both screening and confirmatory tests for hepatitis B surface antigen (HBsAg). The Abbott PRISM HBsAg assay is approved to test people who donate blood, blood components, and organs for the hepatitis B virus. The test also may be used to screen blood from cadavers for organ and tissue donation. The Abbott PRISM HBsAg Confirmatory assay is approved to confirm samples found to be reactive by the Abbott PRISM HBsAg assay. Screening and confirmatory tests are performed separately.
"This automated test system increases the efficiency and convenience of screening blood, tissue and organ donors for the hepatitis B virus," Jesse Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research, said in announcing the approval in July. "Improvements in blood donor screening and testing over the last few years have helped make the nation's blood supply safer from infectious diseases than it has been at any other time."
Hepatitis B is caused by a virus that infects the liver. The virus, which is transmitted by blood, can, in some cases, cause lifelong infection, scarring (cirrhosis) of the liver, liver cancer, liver failure, and death. A blood test is the only way to determine whether a donor has hepatitis B infection.
The FDA has approved Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women ages 18 and older. Plan B is often referred to as emergency contraception, or the "morning after pill." It contains an ingredient used in prescription birth control pills—only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen.
Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B, approved in August, will remain available as a prescription-only product for women ages 17 and younger.
Duramed Pharmaceuticals Inc. of Pomona, N.Y., a subsidiary of Barr Pharmaceuticals Inc., will make Plan B available with a rigorous labeling, packaging, education, distribution, and monitoring program. In the CARE (Convenient Access, Responsible Education) program, Duramed commits to
providing consumers and health care professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B
ensuring that distribution of Plan B will be only through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed health care practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription
designing packaging to hold both OTC and prescription Plan B; Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age
monitoring the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and older and prescription Plan B to women younger than 18.
For More Information: www.fda.gov/cder/drug/infopage/planB/
In October 2006, the FDA approved FluLaval, an influenza vaccine to immunize people ages 18 years and older against the strains of influenza virus judged likely to cause seasonal flu in the Northern Hemisphere in 2006–2007. Influenza, a contagious respiratory disease, is commonly called the flu.
With the addition of FluLaval, there are now five FDA-licensed vaccines for the United States for the current influenza season. FluLaval is the second seasonal influenza vaccine approved using the accelerated approval process; GlaxoSmithKline's Fluarix received approval in 2005.
According to the Centers for Disease Control and Prevention (CDC), the manufacturers have projected making a total of about 115 million doses of flu vaccine for the 2006–2007 season, but these projections could change as manufacturing continues.
FluLaval was approved using the FDA's accelerated approval pathway, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of a product's effectiveness. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine will decrease seasonal influenza disease after vaccination.
Safety information was collected from two clinical studies involving about 1,000 adults who received FluLaval. Other data from use of the vaccine in Canada, where FluLaval has been available since 2001, were also evaluated as part of the FDA's safety assessment. After vaccination, the rate and nature of side effects were similar to those seen with other licensed seasonal influenza vaccines. The most commonly reported side effects included pain, redness, and swelling at the injection site and headache, fatigue, and cough.
FluLaval contains inactivated, or "killed," virus and cannot cause flu. People who are allergic to eggs, chicken proteins, or any other components of the vaccine should not receive FluLaval. The vaccine has not been studied in children and pregnant women.
FluLaval is manufactured by ID Biomedical Corporation of Quebec, a subsidiary of GlaxoSmithKline Biologics, and will be distributed by GlaxoSmithKline, Research Triangle Park, N.C.
Elaprase, the first product for the treatment of Hunter syndrome (Mucopolysaccharidosis II, or MPS II), has been approved by the FDA. Elaprase, approved in July 2006, is a new molecular entity—an active ingredient never before marketed in the United States.
Hunter syndrome is a rare inherited disease that can lead to premature death. It usually becomes apparent in children ages 1 to 3 years. It is a disease in which the person's body is defective in producing the chemical iduronate-2-sulfatase. This chemical is needed to adequately break down complex sugars produced in the body.
Symptoms of the disease include growth delay, joint stiffness, and coarsening of facial features. In severe cases, people experience heart and lung problems, enlargement of the liver and spleen, neurological problems, and death.
The FDA designated Elaprase as an orphan product, one that is generally developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. Hunter syndrome is diagnosed in about 1 out of 65,000 to 132,000 births.
Elaprase was approved after a study of 96 people with Hunter syndrome showed that the treated participants had an improved capacity to walk. At the end of the 53-week trial, people who received Elaprase infusions experienced, on average, a 38-yard greater increase in the distance walked in six minutes compared with those given an inactive product (placebo).
The most serious side effects reported during the trial were hypersensitivity reactions to Elaprase that could be life-threatening, including respiratory distress, drop in blood pressure, and seizure. Other frequent, less serious side effects included fever, headache, and joint pain.
Elaprase is manufactured by Shire Human Genetic Therapies Inc., Cambridge, Mass.
The FDA has granted accelerated approval for Sprycel (dasatinib), a new oral treatment for people with chronic myeloid leukemia (CML), a rare cancer characterized by the uncontrolled growth of white blood cells. CML affects about 4,600 people each year in the United States.
In addition, the FDA approved Sprycel for use in the treatment of adults who have Philadelphia chromosome-positive acute lymphoblastic leukemia
(Ph+ALL), a more serious form of leukemia. Both approvals are for people who have experienced resistance or intolerance to prior therapy.
Sprycel works by reducing the activity of one or more proteins responsible for the uncontrolled growth of leukemia cells. Treatment with Sprycel has been shown to reduce, and in some cases eliminate, detectable leukemia cells in the blood and bone marrow of patients with CML.
The approval of Sprycel is based on evidence from four studies in more than 400 people who were no longer responsive to or tolerant of treatment with Gleevec (imatinib), a drug approved in 2001 for life-threatening leukemia. For people with the earliest stage of CML (chronic phase), treatment with Sprycel resulted in a response in 45 percent of the study participants. Response rates for participants with advanced phases of CML and for Ph+ALL ranged from 31 percent to 59 percent. Response rate was defined as the percent of people who had no detectable leukemia cells or a significant reduction in the number of leukemia cells after treatment. Sprycel is manufactured by Bristol-Myers Squibb Co., Princeton, N.J.
In a separate action, the FDA expanded the use of another leukemia drug, Oncaspar, to include treating children and adults with newly diagnosed acute lymphoblastic leukemia (ALL) as part of a multiple-drug chemotherapy regimen. The FDA previously approved Oncaspar in 1994 only for people with ALL who were unable to receive the cancer drug Elspar (L-asparaginase) because they were allergic to that drug.
The use of Oncaspar in place of Elspar reduces the number of drug injections required from 21 injections of Elspar, which has been the standard of care, to three injections with Oncaspar over the 20-week course of treatment.
The approval is based on a study in 118 children conducted by the Children's Cancer Group, a National Cancer Institute-funded cooperative oncology group. In the study, researchers demonstrated that Oncaspar could be substituted safely and effectively for Elspar as part of a multi-drug cancer regimen.
In September 2006, the FDA approved Duodote (atropine and pralidoxime chloride injection) for use by emergency medical services personnel to treat civilians exposed to life-threatening organophosphorus-containing nerve agents, such as sarin, and insecticides. Duodote is manufactured by Meridian Medical Technologies Inc., Columbia, Md.
The FDA previously approved atropine and pralidoxime chloride injection under the name Antidote Treatment—Nerve Agent Auto-Injector (ATNAA) for military use. Developed by the U.S. Army and manufactured by Meridian Medical Technologies Inc., ATNAA is not available for use in civilians.
ATNAA was approved in January 2002 for use by the military to treat troops who have been exposed to toxic nerve agents that cause loss of muscle control and death from respiratory failure. The two constituent drugs in ATNAA previously were approved for use separately.
"Today's approval facilitates the stockpiling of the product so that it can be used to treat civilians in an emergency," says Douglas Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research. "The approval contains two caveats: the primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective clothing; and Duodote may be administered only by well-trained emergency medical personnel."
The manufacturer will distribute Duodote directly to emergency medical service organizations or to their suppliers.
The FDA is warning consumers not to purchase or use high-strength hydrogen peroxide products for medicinal purposes, including a product marketed as "35 Percent Food Grade Hydrogen Peroxide." These products can cause serious harm or death when ingested. Consumers who are using high-strength hydrogen peroxide in this manner should stop immediately and consult their health care provider.
The FDA has never approved high-strength hydrogen peroxide to be taken internally and considers hydrogen peroxide at 35 percent strength dangerous, even if handled according to the manufacturer's directions. This high-strength hydrogen peroxide is highly corrosive. It's more than 10 times stronger than the solution used in over-the-counter drugs to disinfect minor cuts.
Ingesting hydrogen peroxide can cause gastrointestinal irritation or ulceration. Intravenous (IV) administration of hydrogen peroxide can cause inflammation of the blood vessel at the injection site, bubbles in blood vessels (gas embolisms), and potentially life-threatening allergic reactions.
The agency is working to stop companies selling high-strength hydrogen peroxide from making illegal medical claims about their products, which do not have FDA approval. In July 2006, the FDA issued Warning Letters to two firms illegally selling "35 percent hydrogen peroxide" products on Web sites for the treatment of AIDS, cancer, emphysema, and other serious and life-threatening diseases.
The FDA also warned consumers in April 1989 about the illegal promotion of industrial-strength hydrogen peroxide to treat AIDS and cancer, after at least one related death in Texas and after several injuries requiring hospitalization.
The FDA has approved the use of Plavix (clopidogrel) for people who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), and who are not going to have coronary artery repair (angioplasty).
A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. Each year, an estimated 500,000 Americans have a STEMI heart attack, according to the American Heart Association. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke, and possibly death.
The FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome. Platelets are sticky blood cells that help form a clot, and can contribute to blocked coronary arteries.
Two studies support the effectiveness of Plavix in treating STEMI heart attack patients. A large trial, the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix—when combined with other standard treatments including thrombolysis, a procedure to dissolve clots—reduced mortality and also reduced the combined number of recurrent heart attacks, strokes, and deaths. COMMIT was a randomized, double-blind, placebo-controlled trial of 46,000 patients conducted in China.
The findings in COMMIT are supported by results of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY showed that the coronary artery blood flow was better with clopidogrel treatment compared with placebo.
Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or low platelet counts with spontaneous bleeding and clotting (thrombotic thrombocytopenic purpura).
Plavix is manufactured by Sanofi Aventis of Bridgewater, N.J.
Under the Humanitarian Use Device (HUD) provisions of the Food, Drug, and Cosmetic Act, the FDA has approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart.
The AbioCor Implantable Replacement Heart, made by Abiomed Inc., Danvers, Mass., was approved in September 2006. It is intended for people who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. In clinical studies, this product was shown to prolong the life and improve the quality of life for critically ill patients.
The AbioCor system consists of a two-pound mechanical heart that takes over the pumping function of the diseased heart, which is removed during the implantation procedure. There is a power transfer coil that powers the system across the skin and recharges the internal battery from the outside.
A controller and an internal battery are implanted in the patient's abdomen. The controller monitors and controls the functioning of the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to one hour. The system also includes two external batteries that allow free movement for up to two hours.
In addition to meeting other criteria, patients must undergo a screening process to determine whether their chest volume is large enough to hold the device before they can receive the artificial heart.
Devices approved under the HUD provisions are those intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States. Similar to the Orphan Drug Act, the HUD provisions were designed to encourage development of innovative medical devices to treat rare conditions. They allow medical devices to be approved for market if they demonstrate safety and probable benefit.
The FDA based approval on the company's laboratory and animal testing, and on a small clinical study of 14 patients conducted by Abiomed. The study showed that the device is safe and has likely benefit for people with severe heart failure whose death is imminent and for whom no alternative treatments are available.
"FDA recognizes that not all patients who are eligible will choose this option, but for many patients faced with death, the chance to have additional time with family and friends—however limited—is a chance they are willing to take," says Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "The FDA is requiring the company to provide patients and families a comprehensive patient information package that clearly describes the risks and probable benefits of the device, and explains what patients should expect before, during, and after surgery.
The FDA has approved several generic versions of Boehringer Ingelheim's Mobic (meloxicam) tablets. Meloxicam is indicated for the treatment of osteoarthritis.
"This is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives to brand name drugs," Gary Buehler, director of the FDA's Office of Generic Drugs (OGD), said in announcing the July 2006 approval. "Meloxicam is a widely-used nonsteroidal anti-inflammatory drug (NSAID), and its generic versions can bring significant savings to the millions of Americans with osteoarthritis."
The approval of meloxicam was the result of a "cluster" review approach, one of the process improvements the FDA has instituted to facilitate the review of generic drug applications. The OGD has begun to review groups of applications submitted at the end of five-year new chemical entity (NCE) exclusivity in "clusters" to increase efficiency and decrease review time. At the expiration of five-year exclusivity, the FDA often receives multiple applications from different sponsors, submitted on the same day.
In the case of meloxicam, the OGD received more than 20 abbreviated new drug applications (ANDAs), and efforts of the FDA's review team resulted in approval of 13 generic applications for this product in a little over nine months of review time. This is the first time that any generic version of this product has been available.
Because all the patents have expired for Mobic, approval of meloxicam is likely to represent immediate savings to the American public. In 2005, Mobic was ranked 38th in dollar sales of brand-name drugs in the United States, with sales totaling $916,397,000, according to the online magazine, Drug Topics.
Generic drugs are used to fill more than 50 percent of all prescriptions. Because they can cost a fraction of the price of brand-name drugs, the economic impact of the FDA's generic drug program is significant. With this in mind, the OGD continues working expeditiously to review and take action on generic drug applications.
The FDA is alerting the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan Inc. One Touch Blood Glucose Monitors used by people with diabetes to measure their blood glucose.
The counterfeit test strips potentially could give incorrect blood glucose values—either too high or too low—which might result in a patient taking either too much or too little insulin and lead to serious injury or death. No injuries have been reported to the FDA to date.
The counterfeit test strips are
Consumers who have the counterfeit test strips should stop using them, replace them immediately, and contact their physician. Consumers with questions may contact the company at (866) 621-4855.
The counterfeit test strips were distributed to pharmacies and stores nationwide—but primarily in Ohio, New York, Florida, Maryland, and Missouri—by Medical Plastic Devices Inc., Quebec, and Champion Sales Inc., Brooklyn, N.Y.
The counterfeit test strips can be identified by the following characteristics:
LifeScan alerted the FDA to the counterfeit test strips. The agency is investigating the matter.
LifeScan is alerting the public via a press release and is notifying pharmacists, distributors, and wholesalers through a letter. In its letter, the company is advising customers to contact their original source of supply for restitution. Visit www.GenuineOneTouch.com for updates and for more information.
The FDA is alerting its Counterfeit Alert Network partners, a coalition of health care professional, consumer, and trade associations, which have agreed to further disseminate this important information in a timely and effective manner.
Any adverse reactions experienced with the use of this product, and quality problems, should also be reported 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 through the MedWatch Web site at www.fda.gov/medwatch/