FDA Marks 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR

The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people
infected with and affected by HIV/AIDS worldwide.

The PEPFAR program is a cooperative effort that involves the Food and Drug Administration (FDA) and other HHS agencies, the State Department's Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many other international partners.

"This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS," said HHS Secretary Kathleen Sebelius.

To date, more than 100 products have been assessed by the FDA and either fully or tentatively approved in association with the PEPFAR program. Of these, 29 have been new products and 71 have been generic copies of previously authorized antiretroviral products in the United States.
Twenty-two of these new products are new combinations or regimens that have not previously been authorized in the United States. In addition, there are seven new pediatric products considered innovative for patients in developing economies.

"As we recognize the 100th product authorized in this program, it is estimated that FDA's actions are allowing PEPFAR to spend $150 million more each year on patient access to care," FDA Commissioner Margaret A. Hamburg, M.D., told those attending an event marking the approval at the Pan American Health Organization (PAHO) headquarters in Washington, D.C.
"I look forward to developing and expanding FDA's international collaborations."

As of Sept. 30, 2008, the most recent figure available, PEPFAR supported life-saving antiretroviral treatment for more than 2.1 million men, women, and children living with HIV/AIDS. In fiscal year 2008, PEPFAR provided nearly $1.6 billion in support of treatment programs, including antiretroviral drugs and services.

"PEPFAR is committed to supporting partner countries to build and maintain sustainable procurement and supply chain systems," said U.S. Global AIDS Coordinator Eric Goosby.

Drug products used in PEPFAR receive a "tentative approval" and cannot be approved for marketing in the United States because of existing patents and marketing exclusivity. However, these products meet all the FDA's manufacturing quality, clinical safety, and efficacy requirements to produce them using the same standards as required for marketing in this country.

FDA performs all of its reviews of applications received in association with the PEPFAR on an expedited basis. After receiving approval or tentative approval from FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows FDA to share data from its evaluations with the WHO team in Geneva.

"Improving access to good quality medicinal products is a core objective of public health efforts and one with a direct and measurable impact on health," said Margaret Chan, M.D., director-general of WHO. The goal of PEPFAR is to work with host nations to support treatment of at least 3 million people, prevention of 12 million new infections, and providing care for more than 12 million HIV-infected and affected people by 2013. In addition, PEPFAR will support training of at least 140,000 health care workers in HIV/AIDS prevention, treatment, and care.

"We need to urgently and actively implement strategies to promote greater affordability of both first and second line HIV/AIDS antiretrovirals," said Mirta Roses, M.D., director of PAHO, an
international public health agency that works to improve health and living standards in the Americas. "PEPFAR has made a tremendous difference in the health of disadvantaged people."

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FDA Clears a Test for Ovarian Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," said Jeffrey Shuren, M.D., J.D., acting director of the FDA's Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

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FDA Approves New Cholesterol-Lowering Drug

The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.

"Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke," said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

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FDA Approves Colchicine for Acute Gout, Mediterranean Fever

The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. The FDA has an initiative underway to bring unapproved, marketed products like colchicine under its regulatory framework. This initiative promotes the goal of assuring that all marketed drugs meet modern standards for safety, effectiveness, quality and labeling.

Physicians historically have given colchicine hourly for acute gout flares until the flare subsided or they had to stop treatment because the patient began experiencing gastrointestinal problems. A dosing study required as part of FDA approval demonstrated that one dose initially and a single additional dose after one hour was just as effective as continued hourly dosing for acute gout flares, but much less toxic. As a result, the drug is being approved for acute gout flares with the lower recommended dosing regimen.

The FDA is alerting healthcare professionals to this new dosing regimen and also warning about the potential for severe drug interactions when patients take colchicine.

The medicinal value of using colchicum was first identified in the first century A.D. and its use for treating acute gout dates back to 1810. Physicians have prescribed the medication since then. Although single-ingredient colchicine has not been approved by the FDA until now, a combination product containing colchicine and an agent that increased the excretion of uric acid in the urine was approved by the FDA in 1939.

FMF is the most common of the hereditary periodic fever syndromes and is characterized by recurrent episodes of fever, arthritis and painful inflammation of the lining layers of the lungs and abdomen. Though rare in the United States, it is more common in Mediterranean countries. Physicians have prescribed colchicine for FMF for many years based on studies showing that it reduced the frequency of attacks but use of colchicine for FMF had never been approved. With this approval, Colcrys becomes the first drug approved to treat FMF.

Colcrys is manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia.

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FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today (July 31) approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

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FDA Approves Multaq to Treat Heart Rhythm Disorder

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure. The drug’s label will contain a boxed warning, the FDA’s strongest warning, cautioning that the drug should not be used in severe heart failure patients.

“Multaq represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

In a multinational clinical trial with more than 4,600 patients, Multaq reduced cardiovascular hospitalization or death from any cause by 24 percent, when compared with an inactive pill (placebo). Most of that effect represents reduced hospitalizations, especially hospitalizations related to atrial fibrillation. Atrial fibrillation and atrial flutter cause the heart to beat abnormally fast and sometimes prevent blood from being properly pumped out of the heart.

The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength.

Multaq is manufactured by Paris-based sanofi-aventis.

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Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices

/PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to update its previous recommendations and include IXIARO, a new Japanese Encephalitis (JE) vaccine for travelers to countries in Asia where the disease is endemic, as well as Americans living in such high-risk areas.

ACIP made significant changes to their previous Japanese Encephalitis recommendations, last updated in 1993, noting that many more travelers are now visiting areas where the disease is endemic. In addition to recognizing the recent licensure of IXIARO, the committee's expanded recommendations urged clinicians to consider vaccinating travelers visiting endemic areas during the transmission season, even those on short-term visits, if they plan to spend a substantial amount of time outdoors. The panel also concluded that IXIARO, which is derived from a well-established cell line and does not contain stabilizers or preservatives, has a lower risk of vaccine-associated adverse events than older Japanese Encephalitis vaccines.

IXIARO received marketing approval from the U.S. Food and Drug Administration on March 30, 2009 on the basis of studies that showed the vaccine is highly immunogenic after only two doses. IXIARO has been shown to stimulate a long-lasting immune response and to be well tolerated. It is the only currently manufactured Japanese Encephalitis vaccine available in the United States. IXIARO was developed by Intercell AG; the rights to market and distribute the vaccine to the private sector in the United States are held by Novartis Vaccines.

"The consequences of contracting this disease can be devastating due to the high morbidity and mortality associated with the disease, making IXIARO a crucial preventive tool for those spending time in endemic areas. It is gratifying that the ACIP committee of the CDC has chosen to broaden its recommendations and to recognize the benefits of IXIARO," said Gerd Zettlmeissl, Chief Executive Officer of Intercell. "This underscores our commitment to serving the needs of the travelers' and of the military market and developing vaccines to address unmet needs."

The ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance on the control of vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to children and adults in the civilian population. The ACIP is the only entity in the federal government that makes such recommendations.

About Japanese Encephalitis

Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to 50,000 individuals a year, causing 10,000 to 15,000 deaths (both probably an underestimate due to underreporting and misdiagnosis). Up to 50 percent of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia and the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia, including India and China. As there is no specific treatment for JE, health care experts recommend vaccination as the only highly effective protection for the travelers and military personnel who live in or travel to areas where the virus circulates.

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FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under

The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.

Plan B was first approved in 1999 for prescription use only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc., of Cincinnati.

In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescription-only product for women ages 17 and under. Today's approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc., based in Corona, Calif.

Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.

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FDA Approves Cambia™ for Migraine

(BUSINESS WIRE)--Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug (“NSAID”) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.

Cambia™, formulated with KPA’s patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia™ was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. Cambia™ was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.

“The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa,” said William Maichle, Chief Operating Officer of Kowa Pharmaceuticals America, Inc. “Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia™ addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”

KPA obtained exclusive U.S. and Canadian marketing rights for Cambia™ from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover Cambia™ through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect Cambia™ to launch in 4th quarter 2009.

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FDA Approves Injectable Form of Ibuprofen

The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

“Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

Caldolor will be available for hospital use only. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

In a clinical trial of 319 women who had undergone an elective abdominal hysterectomy, patients were less likely to request morphine for pain on an as-needed basis when administered Caldolor.

Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, at risk of blood clots and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported in the controlled clinical trials were nausea, flatulence, vomiting, and headache.

Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville, Tenn.

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FDA Approves Besivance to Treat Bacterial Conjunctivitis

The U.S. Food and Drug Administration today approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

“Bacterial conjunctivitis is a common condition that affects people of all ages,” said Wiley A. Chambers, M.D., acting director of the Division of Anti-Infective and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others.”

Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms of bacterial conjunctivitis can include red eyes, swelling, eyelids sticking together, itching, watering and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis is generally a condition that runs its course in 7-14 days.

Patients using the drug in clinical trials had a faster rate of resolution of the infection than those treated with a solution containing only a preservative. The drug was shown to be effective in treating patients age one year and older.

Adverse events were reported in less than 3 percent of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache. Besivance is an eye drop for topical use on the eyes only. It should not be injected into the eye.

Besivance is made by Bausch & Lomb, Rochester, N.Y.

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FDA Approves Samsca to treat Hyponatremia

The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.

“With the approval of Samsca, physicians will have an additional tool to treat hyponatremia,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

Samsca is approved to treat hyponatremia associated with congestive heart failure, liver cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.

When sodium levels drop in the fluid outside of cells throughout the body, water moves into cells to balance the sodium levels and causes the cells to swell. Swelling of the brain cells is thought to cause many of the symptoms of hyponatremia. Those symptoms may include fatigue, weakness, headache, nausea, confusion or decreased consciousness, and convulsions. Severe hyponatremia, which has not been studied with Samsca, can lead to coma and death.

Samsca helps raise sodium levels in the blood by removing extra body water in the urine. Patients using the drug in clinical trials had a greater degree of increase in sodium levels in the blood compared with patients taking a pill containing no active drug (placebo).

Samsca is being approved with a boxed warning to alert health care professionals and patients that the drug should be started only in a hospital where blood sodium can be monitored closely. Too rapid a rise in sodium can cause a serious condition called osmotic demyelination syndrome (ODS). ODS can lead to coma or death and can also cause symptoms such as trouble speaking, trouble swallowing, drowsiness, confusion, mood changes, seizures and trouble controlling body movement with muscle weakness in the arms and legs.

Although no cases of ODS were seen in clinical trials of Samsca, ODS is a known risk and it is essential that physicians be aware of it and avoid rapid rises in sodium. Additionally, the FDA is requiring a Risk Evaluation and Mitigation Strategy that requires a patient Medication Guide be given out when the drug is dispensed. The Medication Guide will provide information about the drug’s benefits and risks.

The most common adverse reactions with use of Samsca reported by patients in clinical trials include thirst, dry mouth, weakness, constipation, making large amounts of urine, urinating often, and increased blood sugar levels.

Samsca is marketed by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.

FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis

The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.

“Today’s approval provides another treatment option for patients with these three debilitating disorders,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class."

Simponi is injected under the skin. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.

In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.

Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. Like other TNF- α blockers, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber’s understand the drug’s risks.

The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion.

Simponi is marketed by Centocor Ortho Biotech Inc., Malvern, Pa.

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American Biotech Labs(R) Obtains FDA Approval for New Wound Care Gel Product

/PRNewswire / -- American Biotech Labs, LLC (ABL), developer of a new class of products based on the company's patented nano-catalytic SilverSol Technology(R), today announced that the company has been granted formal approval by the U.S. Food and Drug Administration (FDA) to market its ASAP Wound Dressing Gel throughout the United States. Clifton Mining Company is a major shareholder in American Biotech Labs.

The FDA 510(k) medical device approval letter confirms that ABL may market ASAP Wound Dressing Gel "for the topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations." The product utilizes ABL's innovative SilverSol Technology, which has garnered multiple patents in the U.S. and several countries throughout the world, including a broad-use patent that provides the company with exclusive rights to use its silver-based products to combat many of the world's most destructive pathogens, including malaria, tuberculosis, MRSA and HIV.

"We are delighted with the FDA's decision to grant approval for ABL to broadly market our ASAP Wound Dressing Gel," said Dr. William Moeller, a managing director of American Biotech Labs. "We feel this is a singularly effective wound care product, and it is a tremendous validation for us that ABL products have now received approval from the FDA as well as from the EPA."

ABL has performed extensive anti-microbial studies against bacteria, yeast, fungus and other pathogens. Information about these studies is available at research section of the ABL Website, www.americanbiotechlabs.com/researchprotected/researchmenu.html.

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Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment

(BUSINESS WIRE)--Sciele Pharma, Inc., a Shionogi Company, today announced that the U.S. Food & Drug Administration (FDA) has approved Benzyl Alcohol Lotion 5%, the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. Sciele acquired from Summers Laboratories the rights to this novel, patented product in the United States, Canada and Mexico. The Company expects to launch the product in the third quarter of 2009, in time for peak head lice season.

“We are excited to introduce this novel product to the prescription head lice treatment market. This product will meet the unmet need for an effective treatment that does not contain a neurotoxic chemical and addresses possible resistance issues,” said Ed Schutter, President and Chief Operating Officer of Sciele Pharma. “The approval of this new head lice product marks an important milestone for Sciele’s pediatric portfolio.”

Each year, approximately 6 to 12 million children between the ages of 3 and 12 years are infested with head lice, parasites that survive by injecting small amounts of saliva and removing small amounts of blood from the scalp every few hours(1). To survive, lice breathe through sophisticated spiracles that close upon contact with most liquids, allowing the lice to go into suspended animation and survive for hours without respiration. The mechanism of action of Sciele’s product is facilitated through the use of benzyl alcohol which prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.

“Head lice are an all-too-common and challenging medical problem that causes anxiety in families, schools and summer camps,” said Ira A. Pion, MD, Clinical Assistant Professor, Department of Dermatology, New York University Medical Center. “Sciele’s new product should be welcomed by health professionals and parents as a safe and effective treatment option that treats children with head lice without the use of harsh chemicals and addresses concerns about the increased resistance of lice to therapies that contain neurotoxic chemicals.”

Sciele is working with professional organizations, such as the National Association of School Nurses, to educate health professionals and the public about head lice. The Company has assembled a national advisory board of leading head lice experts from various medical specialties (pediatrics, dermatology, family practice and clinical research) to provide guidance on these efforts. Full prescribing information is available at www.sciele.com.

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FDA Approves Drug for an Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.

Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.

"Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing."

Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.

The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.

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FDA Approves Cardiac Adhesion Barrier for Pediatric Use

The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.

Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.

Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis, or chest. Cardiac adhesions bind the outer membrane of the heart to surrounding tissue, which may restrict heart activity and complicate any additional surgical treatment. While scar tissue is part of the body’s natural healing response, adhesions can become densely fibrous and difficult to surgically navigate, which can pose problems for patients who require repeat surgeries.

In the United States, there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected while other children require additional operations as they grow. This product gives physicians another tool to help decrease this type of complication that may occur.

Repel-CV is intended for children who are likely to require additional heart surgery. In a clinical study, patients who received Repel-CV were found to have less area of severe adhesions—21 percent of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47 percent of the surgical site.

“Designing and testing medical devices for children is challenging because they are still growing,” said Daniel G. Schultz, director of FDA’s Center for Devices and Radiological Health. “Approval of Repel-CV is an example of FDA’s commitment to work with regulated industry to make more safe and effective pediatric medical devices available.”

Repel-CV is manufactured by SyntheMed Inc. in Iselin, N.J.

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