FDA Approves First Generic Versions of Lamisil Tablets
- Mon, 02 Jul 2007 18:29:00 GMT
The U.S. Food and Drug Administration today approved the first generic versions of prescription Lamisil (terbinafine hydrochloride) tablets, used to treat nail fungus infection (onychomycosis). Such infections occur when fungi invade a fingernail or toenail or the skin underneath the nail.
"This approval offers Americans additional alternatives when choosing medications to treat nail fungus infections," said Gary J. Buehler, R.Ph., director of FDA's Office of Generic Drugs.
FDA approved applications from multiple generic drug manufacturers for terbinafine hydrochloride tablets in 250-milligram formulations. Manufacturers include: Amneal Pharmaceuticals, Apotex Corp., Aurobindo Pharma USA Inc., Dr. Reddy's Laboratories Ltd., Gedeon Richter USA Inc., Genpharm Inc., Glenmark Pharmaceuticals Inc., InvaGen Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Orgenus Pharma Inc., Roxane Laboratories Inc., TEVA Pharmaceuticals USA, Watson Laboratories Inc., Wockhardt USA Inc.
The remaining patent or exclusivity for Lamisil expired on June 30, 2007.
According to the online trade magazine, Drug Topics, Lamisil tablets are the 57th highest selling brand-name prescription drug by retail dollars in the United States.
In addition to terbinafine tablets, FDA also approved an application for a generic version of over-the-counter Lamisil cream (terbinafine hydrochloride,1 percent) to treat athlete's foot, a skin disease caused by a fungus that usually occurs between the toes. The cream is manufactured by Taro Pharmaceuticals U.S.A. Inc.
The FDA's Office of Generic Drugs ensures that generic drugs are safe and effective through a thorough scientific and regulatory process.
For more information:
Office of Generic Drugs
www.fda.gov/cder/consumerinfo/generic_equivalence.htm.
Generic Drugs: What You Need to Know
www.fda.gov/fdac/features/2002/502_generic.html.
FDA monthly reports for first-time generics
www.fda.gov/cder/ogd/approvals/
FDA Warns Consumers Not to Eat Veggie Booty Snack Food
- Thu, 28 Jun 2007 23:18:00 GMT
The U.S. Food and Drug Administration is warning consumers not to eat Veggie Booty flavor of snack food, marketed by Robert's American Gourmet, due to possible contamination with Salmonella Wandsworth, bacteria that cause gastrointestinalillness.
FDA advises consumers to throw away any Robert's American Gourmet brand Veggie Booty they have in their home. Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce, and one-half ounce packages. No other flavors or varieties of snack food marketed by Robert's American Gourmet have been associated with Salmonella Wandsworth contamination.
Veggie Booty is often consumed by children, so parents are encouraged to watch their children, and seek medical care if they observe signs of illness.
Individuals who have recently eaten Veggie Booty and who have experienced any of the symptoms described below should contact a doctor or other health care provider immediately. Any such illnesses in persons with a recent history of eating Veggie Booty should be reported to state or local health authorities.
This warning is based on 52 reports of illness across 17 states, beginning in March 2007. Almost all the illnesses have occurred in children under 10 years old, with the most cases in toddlers. Most persons had reported bloody diarrhea; four were hospitalized. FDA learned of the illnesses on June 27 from the Centers for Disease Control and Prevention, which conducted an investigation of the illnesses with state and local health officials. The outbreak is considered likely to be ongoing.
Salmonella typically causes diarrhea (may be bloody); the diarrhea is often accompanied by abdominal cramps and fever. Symptoms typically begin within one to four days after exposure to the bacteria. In infants, persons with poor underlying health and those with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.
States reporting illnesses include: California (seven cases), Colorado (five cases), Connecticut (one case), Georgia (one case), Indiana (one case), Massachusetts (three cases), Minnesota (two cases), New Hampshire (two cases), New Jersey (two cases), New York (13 cases), Oregon (one case), Pennsylvania (three cases), Tennessee (one), Texas (one), Vermont (three cases), Washington (four cases), and Wisconsin (two cases).
Robert's American Gourmet, of Sea Cliff, N.Y., which markets Veggie Booty, and its contract manufacturer, are fully cooperating with FDA's investigation into the cause of the contamination. Manufacturing and distribution of this product has ceased, and Robert's American Gourmet is recalling all potentially contaminated product, including all expiration dates and lot codes. The product is sold in all 50 states and Canada at retail locations and over the Internet.
FDA’s comprehensive investigation has begun at the manufacturing facility, focused on identifying the source of the contamination. Product samples have been collected and will be analyzed in FDA laboratories. Typical microbiological analysis takes approximately seven days. The Centers for Disease Control and Prevention are also continuing their investigation in close collaboration with state health departments and FDA. FDA will provide additional updates as the investigation progresses and more information becomes available.
FDA Detains Imports of Farm-Raised Chinese Seafood
- Thu, 28 Jun 2007 19:19:00 GMT
En Español | 
The Food and Drug Administration (FDA) today announced a broader import control of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. FDA will start to detain these products at the border until the shipments are proven to be free of residues from drugs that are notapproved in the United States for use in farm-raised aquatic animals.
This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.
"We're taking this strong step because of current and continuing evidence that certain Chinese aquaculture products imported into the United States contain illegal substances that are not permitted in seafood sold in the United States," said Dr. David Acheson, FDA's assistant commissioner for food protection. "We will accept entries of these products from Chinese firms that demonstrate compliance with our requirements and safety standards."
During targeted sampling from October 2006 through May 2007, FDA repeatedly found that farm-raised seafood imported from China were contaminated with antimicrobial agents that are not approved for this use in the United States.
The contaminants were the antimicrobials nitrofuran, malachite green, gentian violet, and fluoroquinolone. Nitrofuran, malachite green, and gentian violet have been shown to be carcinogenic with long-term exposure in lab animals. The use of fluoroquinolones in food animals may increase antibiotic resistance to this critically important class of antibiotics.
None of these substances is approved for use in farm-raised seafood in the United States, and the use of nitrofurans and malachite green in aquaculture is also prohibited by Chinese authorities. Chinese officials have acknowledged that fluoroquinolones are used in Chinese aquaculture and are permitted for use in China.
The levels of the drug residues that have been found in seafood are very low, most often at or near the minimum level of detection. FDA is not seeking recall of products already in U.S. commerce and is not advising consumers to destroy or return imported farm-raised seafood they may already have in their homes. FDA is concerned about long term exposure as well as the possible development of antibiotic resistance.
The FDA action includes conditions under which an exporter can be exempted from FDA's detention action by providing specified information to the agency. This information must demonstrate the exporter has implemented steps to ensure its products do not contain these substances and that preventive controls are in place. The additional import controls placed on seafood from China will last as long as needed.
FDA may allow the entry into the United States and subsequent distribution into the marketplace of individual shipments of the Chinese farm-raised seafood products if the company provides documentation to confirm the products are free of residues of these drugs.
FDA Clears for Marketing First Quick Test for Malaria
- Tue, 26 Jun 2007 20:57:00 GMT
The U.S. Food and Drug Administration has cleared for marketing the Binax NOW Malaria Test, the first authorized U.S. rapid test for malaria, a mosquito-bornedisease caused by a parasite. The test is intended for laboratory use.
Standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope, a difficult task that requires training and experience.
The Binax NOW test is significantly faster and easier to use. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can also differentiate the most dangerous malaria parasite, Plasmodium falciparum, from less virulent malaria parasites. Results still need to be confirmed using standard microscopic evaluation.
People infected with malarial parasites often experience a high fever, chills, and flu-like illness. Left untreated, they may develop severe complications and die.
Although malaria has been eliminated from the United States since the 1950s, it can still affect U.S. residents who travel or who work in other countries. According to the Centers for Disease Control and Prevention, there were 1,528 newly-reported cases of malaria in the United States in 2005, including seven deaths. Nearly all deaths can be prevented if the infection is diagnosed and treated early.
"Since malaria is uncommon in the United States, clinicians and lab personnel may not be accustomed to diagnosing this disease," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "When used in combination with other laboratory tests, the Binax NOW test provides an additional tool to help them diagnose this disease faster in the United States."
The Binax NOW test was 95 percent accurate compared with standard microscopic diagnosis in a multi-center study outside the United States in areas where malaria is prevalent.
The Binax NOW test is manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc. of Scarborough, Me.
For more information on malaria consult CDC at www.cdc.gov/malaria/.
FDA Issues Dietary Supplements Final Rule
- Fri, 22 Jun 2007 16:30:00 GMT
The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a qualitymanner, do not contain contaminants or impurities, and are accurately labeled.
"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA."
The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, Ph.D., director of FDA'sCenter for Food Safety and Applied Nutrition.
Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.
The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.
The final rule includes flexible requirements that can evolve with improvements in scientific methods used for verifying identity, purity strength, and composition of dietary supplements.
As a companion document, FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing of specific dietary ingredients used in the processing of dietary supplements.
Under the interim final rule the manufacturer may be exempted from the dietary ingredient identity testing requirement if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. FDA is soliciting comment from the public on the interim final rule. There will be a 90-day comment period, ending on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.
The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.
Backgrounder: http://www.cfsan.fda.gov/~dms/dscgmps7.html
Fact Sheet: http://www.cfsan.fda.gov/~dms/dscgmps6.html
To see a consumer article called "Final Rule Promotes Safe Use of Dietary Supplements," visit http://www.fda.gov/consumer/updates/dietarysupps062207.html.
FDA Approves First Drug for Treating Fibromyalgia
- Thu, 21 Jun 2007 20:08:00 GMT
The U.S. Food and Drug Administration today approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.
Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.
"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder."
Persons with fibromyalgia typically experience long-lasting or chronic pain, as well as muscle stiffness and tenderness. Fibromyalgia affects about 3 million to 6 million people in the United States each year. The disorder mostly affects women and typically develops in early-to-middle adulthood.
There is no test for the diagnosis of fibromyalgia. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions.
Individuals with fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but, the mechanism by which Lyrica produces such an effect is unknown.
Two double-blind, controlled clinical trials, involving about 1,800 patients, support approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams per day.
The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and attention. FDA advises that patients talk to their doctor or other health care professional about whether use of Lyrica may impair their ability to drive.
Lyrica already is approved for treating partial seizures, pain following the rash of shingles and pain associated with diabetes nerve damage (diabetic neuropathy).
Lyrica is manufactured by New York-based Pfizer Inc. Pfizer has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.
To see a consumer article called Living with Fibromyalgia, First Drug Approved, visit
www.fda.gov/consumer/updates/fibromyalgia062107.html
Food and Drug Administration Press Releases
- Thu, 26 Jul 2007 22:48:00 GMT
On July 24, 2007 the U.S. Food and Drug Administration (FDA) was informed by Targeted Genetics Corporation of Seattle about the death of a patient who received an investigational gene therapy product in a clinical trial for thetreatment of active inflammatory arthritis.
FDA's condolences go to the patient's family.
FDA is providing this preliminary information in recognition of the public's interest in these types of new therapies.
Targeted Genetics notified FDA earlier that a patient in its trial experienced a serious adverse event. Even though the cause of the illness wasn't known, and is still uncertain, the agency immediately placed the trial on clinical hold--meaning no further product can be administered and no new patients can be enrolled.
The product that was being studied uses a particle called a vector that is designed to deliver treatment genes to target cells. The vector used is a recombinant adeno-associated virus (AAV) derived vector and delivers the gene for Tumor-Necrosis Factor -Receptor, with the intent to inhibit a key mediator of inflammation. In the study, the gene therapy was administered into the joint affected by the disease to reduce inflammation and disease in patients with active inflammatory arthritis.
More than 100 subjects have been enrolled in the trial, according to the company, without known similar serious events. However, the patient's illness was related in time to the receipt of a second injection of the product. Upon being alerted to the adverse event, FDA immediately began its investigation to determine whether the illness was related to the treatment. The investigation into the cause of the patient's illness and subsequent death is intensive and ongoing.
Targeted Genetics is cooperating with FDA's investigation and has agreed to provide the agency with ongoing results from various tests and all other information it is compiling that may help determine the cause of this patient's death. FDA is also coordinating with the National Institutes of Health in an effort to acquire a better understanding of the potential scientific and safety implications of this event. These matters will be discussed at the September meeting of the NIH Recombinant DNA Advisory Committee.
FDA is not aware of similar adverse events occurring in other gene therapy trials either with this specific product or with those that use other genes in AAV vectors. However, as a precaution, the agency is further reviewing all ongoing trials involving any use of AAV.
FDA recognizes the contributions of participants in clinical trials and places a high priority on potential safety issues – volunteers play a critical role in making treatments available that have the potential to help many other patients who need new treatments for serious diseases.
The agency is continuing to obtain and assess additional information to help determine, if possible, the cause of the event, and any potential implications and will take additional steps and provide updates as warranted.
Food and Drug Administration Press Releases
- Fri, 27 Jul 2007 13:25:00 GMT
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).
At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.
"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."
Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.
Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.
Physicians with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA’s Division for Drug Information about other options at 888-463-6332.
For more information:
Novartis Zelnorm Web page
www.zelnorm.com
National Institute of Diabetes and Digestive and Kidney Diseases—Irritable Bowel Syndrome
http://digestive.niddk.nih.gov/ddiseases/pubs/ibs/
International Foundation for Functional Gastrointestinal Disorders
www.iffgd.org
FDA Center for Drug Evaluation and Research
www.fda.gov/cder
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