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Feb20
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sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution. Xyzal is an oral antihistamine, available only by prescription, for the relief of symptoms associated with indoor and outdoor allergies and is also indicated for the treatment of chronic idiopathic urticaria. The tablet form of Xyzal received FDA approval in May, 2007 and both the tablet and oral formulations are now approved for use in adults and children over the age of 6.
"The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Paediatrics and Medicine at the University of Tennessee Health Science Centre in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
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Feb13
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Duragesic painkiller patches contain fentanyl have been recalled due to a flaw that could cause patients, or even caregivers, to overdose on the drug.Sold by PriCara in the United States and generically by Sandoz Inc the recall includes all 25-micro-gram-per-hour...
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Feb 8
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Company Name, Symbol, Share Price, ChangeAbbott Laboratories' (NYSE:ABT) - $56.80 -1.30 (-2.24%) AstraZeneca (NYSE:AZN) - $37.96 -0.76 (-1.96%) Bristol-Myers Squibb (NYSE:BMY) - $23.07 -0.27 (-1.16%) Eli Lilly & Co. (NYSE:LLY) - $50.23 -0.99 (-1.93%) GlaxoSmithKline(NYSE:GSK) - $42.16 -0.23 (-0.54) Merck & Co. (NYSE:MRK) -...
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The positive effects of the antidepressant trazodone’s have been revealed to be statistically significant. One such positive effect being the normalization of sleep patterns of those involved in the study. This means more sleep and less times awakening during the...
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Here we are at the end of another week and based on the week's articles the FDA has been busy. There are however a number of articles that I haven't covered. Some aren't exactly pharma related but I still think...
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The U.S. Food and Drug Administration warned that the anti-wrinkle drug Botox and a competitor Myobloc have been linked to several deaths and other severe side effects consistent with botulism.Both drugs use botulism toxin to block nerve muscles causing them...
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Feb 7
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Mylan Inc. (NYSE: MYL) announced that its pharmaceutical division has obtained an order from a judge in Florida finding that Levothyroxine Sodium should not be on the state's negative drug formulary.A drug that is included on Florida's negative formulary cannot be...
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The U.S. Congress House committee on energy and commerce in taking a closer look at Pfizer's advertisement for Lipitor that was endorsed by Robert Jarvik.Jarvik, inventor of the artificial heart is featured in the ad wearing a white doctor's coat...
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Pharmaceutical Research and Manufacturers of America (PhRMA) have announced the recipients of PhRMA's 2008 Discoverers Award and the 2008 Clinical Trial Exceptional Service Award.PhRMA presented its highest award, The Clinical Trial Exceptional Service Award, to researchers and biopharmaceutical company scientists...
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Teva Pharmaceuticals USA has received U.S. Food and Drug Administration approval to manufacture generic Fosamax.Alendronate sodium tablets are indicated for the treatment of osteoporosis, a condition that causes thinning and weakening of the bones.Approved dosages will be available in three...
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U.S prosecutors and Merck & Co. (NYSE:MRK) officials announced that a settlement has been reached over claims that the pharmaceutical company overcharged Medicaid and had improperly marketed medications to doctors.Merck agreed to settle a Philadelphia case concerning improper Medicaid rebate...
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Researchers in Switzerland found that patients on a regime of channel calcium blocker medication for hypertension for an extended period of time had a 23 percent lower risk of developing Parkinson's than patients not taking that type of drug.The study...
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Some time in the future you may be getting a tattoo, a doctor approved and prescribed tattoo. German scientists believe that tattooing is a more effective way of delivering experimental DNA vaccines than standard injections due to experiments they have been...
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Feb 6
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The National Institutes of Health stopped part of a 10,000 patient Type 2 diabetes study 18 months early due to increased deaths among a vulnerable portion of the study group.The study's focal point was to establish if pushing blood sugar levels...
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The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses,...
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Researchers at the U.S. Centers for Disease Control and Prevention are reporting the AIDS virus can be spread to a child by its mother pre-chewing its food.According to the CDC three such cases were reported in the U.S. between 1993 and...
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A study in Africa and India has established that HIV-infected breast feeding mothers who's babies are given the antiretroviral drug nevirapine have less of a risk of passing the virus on to their babies.The drug is already widely used in developing...
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The European Commission has approved Roche's oral chemotherapy Xeloda for treatment of metastatic colorectal cancer in combination with any chemotherapy with or without Avastin.The approval of the new indication will allow more patients that have colorectal cancer that has spread...
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Naproxen is a non-steroidal anti-inflammatory drug (NSAID) indicated for the reduction of moderate to severe pain, fever, inflammation and stiffness. It is used for conditions such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, injury such as fractures, tendonitis, bursitis, sciatica and...
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Feb 5
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British researchers announced that the results of their latest research failed to show any evidence that there was a link between the mumps, measles, rubella (MMR) vaccine and autism.In what is claimed to be the largest study, researchers looked for...
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Millennium Pharmaceuticals (NASDAQ:MLNM) announced that its multiple myeloma (MM) drug Velcade has been granted priority review by the U.S. Food and Drug Administration. Millenium is looking for a new indication to allow newly diagnosed MM patients to be treated with Velcade.Data...
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Harry Heimberg of the JDRF Center at Vrije Universiteit Brussel, in Belgium, and the Beta Cell Biology Consortium has published a study outlining how scientists isolated pancreatic stem cells in adult mice. Researchers hope the breakthrough could lead to treatment for...
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Schering-Plough Corp (NYSE:SGP) announced that the U.S. Food and Drug Administration has approved its once-a-day asthma corticosteroid inhaler for children. The inhaled steroid for the prevention of asthma attacks can be used with children as young as 4.Asmanex Twisthaler received...
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Feb 4
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The American College of Obstetricians and Gynecologists (ACOG) released a new Practice Bulletin that recommends that pregnant women with asthma should continue to use their asthma medication but in the lowest dosage needed to control their symptoms.The bulletin states that...
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The U. S. Food and Drug Adminstration stated today that it is concerned about excessive sedation following injections of Eli Lilly's long-acting form of its schizophrenia drug Zyprexa.While the drug was found to be effective for acute and long-term treatment of...
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In November the U.S. Food and Drug Administration issued an Early Communication warning that Pfizer's anti-smoking drug Chantrix may be associated with increased suicidal thoughts and aggressive behavior.On Friday the FDA issued a Public Health Advisory announcing that it has...
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The Center for Disease Control and Prevention announced that they are investigating 53 incidents of dialysis patients having developed allergic reactions after receiving injections of heparin made by Baxter Healthcare Corp.Last week Baxter voluntarily recalled specific batches of heparin due to...
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Feb 1
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Once again the week has been filled with medical and pharmaceutical news that I haven't had the chance to write about. I think that each of these is worth your time so check them out.Interesting Articles for Week of February...
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Company Name, Symbol, Share Price, ChangeAbbott Laboratories' (NYSE:ABT) - $57.55 +1.37 (+2.44%) AstraZeneca (NYSE:AZN) - $41.25 -0.85 (-2.02%) Bristol-Myers Squibb (NYSE:BMY) - $23.96 +0.94 (+4.08%) Eli Lilly & Co. (NYSE:LLY) - $51.66 +0.27 (+0.53%) GlaxoSmithKline(NYSE:GSK) - $47.01 -0.37 (-0.78) Merck & Co. (NYSE:MRK) -...
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Advances in curbing the addiction to drugs has revealed a new vaccine that prevents the person from getting high. Could this prevent the downward spiral of addiction that follows relapse? The only available results say that the vaccine decreases the...
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President George W. Bush declared February "American Heart Month" and issued the following proclamation:In acknowledgement of the importance of the ongoing fight against cardiovascular disease, the Congress, by Joint Resolution approved December 30, 1963, as amended (77 Stat. 843; 36...
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Doctors claim that administering magnesium sulfate just before birth can cut the risk of cerebral palsy in half for premature babies. Magnesium sulfate is used to treat high blood pressure due to pregnancy and to stop early labor. Now the...
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An invisible gel condom that protects women against AIDS seems like a fairy tale. But according to the newest reports, Pfizer has passed along, without royalties, their newest HIV drug to a group of researchers that want to find the...
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The U.S. Food and Drug Administration issued an alert yesterday that epilepsy drug could increase the risk of suicidal thought of behaviour.The alert comes as a result of the FDA having reviewed almost 200 studies of 11 anti-seizure drugs that...
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