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December 2006 (Medialink) - Women who rely on oral contraceptives as a means for birth control can now have their pill and chew it, too. The first and only FDA approved chewable birth control pill is now available with a prescription.
The spearmint-flavored daily tablet, called Femcon Fe, formerly named Ovcon 35 Chewable, is designed to provide a convenient, new option for busy women on the go. It can be chewed or swallowed whole and it offers the same ingredients and reliability as the traditional swallowed pill.
New birth control options are important for women, since studies show that 47 percent of women miss one or more pills per month - and missing pills can increase the risk of pregnancy.
Femcon Fe is available in a 28-day regimen in which women take 21 active tablets, followed by seven placebo tablets containing iron. Risks associated with the product are similar to those of other birth control pills and include an increased risk of blood clots, heart attacks and strokes, particularly for smokers over 35 years old.
Produced for Warner Chilcott
DENDREON'S PROVENGE GRANTED 6-MONTH FDA PRIORITY REVIEW FOR TREATMENT OF ADVANCED, LATE-STAGE PROSTATE CANCER
More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease. On January 16, 2007 Dendreon Corporation announced that the FDA has accepted for filing and has assigned priority review status to the Company's Biologics License Application (BLA) for PROVENGE (sipuleucel-T), its investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer. Priority Review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Clinical trials have shown that PROVENGE increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options. PROVENGE may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system to treat cancer.
For more information call 1-866-4-prostate or visit www.dendreon****
FDA Approves LIALDA™ (mesalamine), the First Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis
Basingstoke, UK and Philadelphia, US - January 16, 2007 / PRNewswire / — Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDA™ (mesalamine) with MMX® technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis. Shire will launch LIALDA in the U.S. in the first quarter of 2007.
Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day. A recent study conducted by the Crohn's and Colitis Foundation of America (CCFA) found that 65 percent of patients with ulcerative colitis are poorly compliant with their medication, citing pill burden and inconvenience associated with the medication.
"As the first oral once-a-day treatment option for ulcerative colitis, the approval of LIALDA in the United States is great news for patients and physicians when managing this serious condition," said Matthew Emmens, Shire Chief Executive Officer. "Once-daily LIALDA is one of several medicines Shire expects to launch in the U.S. and Europe in 2007."
The FDA approval was based on the results of two Phase III clinical studies that found LIALDA (2.4 g/day and 4.8 g/day) was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo after eight weeks of treatment. LIALDA is generally well tolerated and has a similar safety profile to other currently available mesalamines.
"In clinical trials, LIALDA proved to be an effective medication, providing superior rates of remission compared to placebo for people with ulcerative colitis," said lead study investigator, Gary R. Lichtenstein, M.D., director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania. "This is the first new mesalamine treatment to enter the market since 2000, filling a major void for physicians and people with ulcerative colitis and simplifying treatment of this disease."
"The introduction of new treatments with more convenient dosing regimens may be an important step in helping patients with ulcerative colitis remain compliant with their medication," said Jonathan Braun, M.D., Ph.D., chair of CCFA's National Scientific Advisory Committee.
Shire has licensed from Giuliani S.p.A. the exclusive rights to develop and commercialize LIALDA in the U.S., Canada, Europe -- known as MEZAVANT™ -- (excluding Italy) and the Pacific Rim. Giuliani S.p.A. retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals S.p.A., Milan developed the MMX technology and owns the trademark, MMX.
For more information on LIALDA, please visit www.LIALDA****.
The U.S. Food and Drug Administration (FDA) has approved Reclast (zoledronic acid) injection for the treatment of Pagets disease of the bone, the second most prevalent bone disease after osteoporosis. Reclast is the first and only single dose treatment regimen for Pagets disease and the first new treatment for the disease in nearly a decade.
Until today, standard therapies for Pagets disease bisphosphonates taken in pill form had to be taken daily for up to six months. Reclast is given as a single 15 minute intravenous infusion by a healthcare professional.
Studies show that Reclast is more effective, offers a longer period of remission and starts working faster than the current standard treatment, Actonel (risedronate sodium). Reclast works by attaching to bone, stopping excessive bone breakdown and rebalancing the bodys natural bone remodeling process. The FDA is currently reviewing Reclast as a potential once yearly treatment for postmenopausal osteoporosis.
For additional information on Reclast, visit www.reclast****.
For more information about Pagets disease, please contact The Paget Foundation at www.paget**** or call 800-23-PAGET (800-237-2438).
FDA APPROVES XYZAL(levocetirizine dihydrochloride) TABLETS FOR THE RELIEF OF SEASONAL AND YEAR ROUND ALLERGIES, AND CHRONIC HIVES
The U.S. Food and Drug Administration (FDA) has just approved Xyzal, a new once-daily prescription antihistamine that delivers a rapid and long-lasting effect for the relief of symptoms associated with seasonal and year round allergies and chronic hives in adults and children six years of age and older.
Estimates from the American College of Allergy, Asthma and Immunology suggest that allergies affect as many as 40 to 50 million people in the United States. As modern living has become more complex, so have allergies with the disease and subsequent allergy seasons becoming longer and more severe. Among others, outdoor pollution, indoor air quality problems, and exposure to airborne and food allergens are all playing a role in the surge in allergies.
Xyzal once-daily tablets are expected to be available during the 2007 fall allergy season.
For more information as well as full prescribing information, visit *******www.ucb-group****/products/allergy_respiratory_pc/xyzal/ or *******products.sanofi-aventis.us/xyzal/xyzal.pdf.
Be My Friend *******www.myspace****/psychtruth
The FDA Conspiracy & Bleached Flour, Austin Nutrition
The truth about white bread.
What is enriched bleached white flour?
Wiki FDA - *******en.wikipedia****/wiki/Fda
Visits Joseph's Website at
This video was produced by Psychetruth
Psychetruth is empowered by TubeMogul
© Copyright 2008 Zoe Sofia. All Rights Reserved.
*******www.therenegadehealthshow**** - So after I posted the organic food vs. conventional food episode demonstration...
I received a bunch of questions about how you can trust that the food you're getting is organic.
Well, if you're shopping in the grocery store, you have to watch out for these lax FDA regulations and loopholes that might leave you with a mouthful of pesticides and other nasty things!
This is some important information, so go ahead and see for yourself...
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FDA Advisory & Big Pharma Conflicts of Interest, Psychology w/ Shannon
Not a conspiracy theory because it's just too easily documented. Members of the FDA Advisory Committees for psychiatry and risk management have major ties to the drug industry.
This video was produced by psychetruth
Psychetruth is empowered by TubeMogul
© Copyright 2008 Zoe Sofia. All Rights Reserved. Distributed by Tubemogul.
Impella 2.5 Cardiac Assist Device Now Available to Doctors and Patients in the U.S.
The U.S. Food and Drug Administration (FDA) just cleared the Impella 2.5 Cardiac Assist Device for immediate use. Designed for cardiac arrest and heart attack patients, it pumps up to 2.5 liters of blood per minute, and supports the heart in situations when it cannot function on its own. Each year over a million people in the U.S. have a heart attack, according to the National Institutes of Health. Of that statistic, half of them die and many are left with permanent heart damage.
As the world's smallest Ventricular Assist Device (VAD), this technology provides patients with immediate, sustained coronary perfusion when their heart is unable to do so. The Impella 2.5 is inserted percutaneously in the catheterization laboratory (cath lab) through the femoral artery into the left ventricle. It is the only device designed to actively unload blood from the ventricle and is approved for short term use for up to six hours.
Today's clearance allows Abiomed to begin selling the device for use to the estimated 14,000 interventional cardiologists at approximately 1,700 heart hospitals in the United States.
For more information, go to www.abiomed****.
Produced for Abiomed, Inc.
Up first, the Boston Celtics celebrated their 17th NBA Championship title Tuesday night after defeating the Los Angeles Lakers in a blowout. The Celtics gained a significant lead early on in Game 6 and finished the home game strong, 131 to 92. This victory is the first of its kind for many Boston players, including MVP Paul Pierce, Kevin Garnett and Ray Allen. Coach Doc Rivers celebrated the win and finally got his hands on the Larry O’Brien trophy, after being doused in Gatorade by the players. The 2008 title marks the first Boston championship in 22 years, and as for the Celtics-Lakers rivalry, the latest champions now have a 9 and 2 record against LA in the finals.
And the California Supreme Court has legalized same-sex marriage. While this recent ruling caused many same-gendered couples to line-up Tuesday for making their commitments legal, the actual first person to pay for the 70-dollar marriage license fee in West Hollywood is ‘Star Trek’s’ George Ta-kay. The 71-year-old actor and his partner of 21 years, 54-year-old Brad Altman, plan to marry on September 14th in LA. The marriage license in the state of California is valid for up to 90 days.
And the FDA is attempting
Help wanted at the FDA. Susan Wichkler, chief of Staff at the FDA, talks about the 1300 job opening at the FDA and how they are combating the drop in public trust, in part thought a weekly blog by FDA commissioner.
In September, the FDA began posting on its web site a list of drugs it is investigating for adverse side effects. The new program is required by Congress, in response to public demand for more transparency in the drug investigation process. Here, Legal Briefs' Amy Yeargan talks about the program.