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Feb20
sanofi-aventis' Xyzal Tablets Get FDA Approval

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.

XyzalThe 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
Duragesic Fentanyl Patches Recalled
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... Continue Reading
Feb 8
Stock Market Fluctuations in Big Pharmas as of February 8, 2008
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) -... Continue Reading
Positive Results for Phase III Study on Once-daily Trazodone
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... Continue Reading
Interesting Articles for Week of February 8
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... Continue Reading
FDA Warns of Children Dying From Botox Injections
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... Continue Reading
Feb 7
Availability of Generic Levothyroxine Restored in Florida
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... Continue Reading
Pfizer's Lipitor Ad Gets U.S. Congress's Attention
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... Continue Reading
GlaxoSmithKline Gets PhRMA's 20th Anniversary Discoverers Awards
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... Continue Reading
Teva Gets FDA Approval for Generic Fosamax
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... Continue Reading
Merck Agrees to Pay $671M to Settle Rebate Accusations
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... Continue Reading
Calcium Channel Blockers May Reduce Parkinson's Risk
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... Continue Reading
Tattooed Vaccines?
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... Continue Reading
Feb 6
NIH Halts Part of Large Diabetes Study
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... Continue Reading
FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine
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,... Continue Reading
Infants Can Contract HIV from Pre-Chewed Food
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... Continue Reading
Nevirapine Reduces of Passing HIV During Breast Feeding
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... Continue Reading
Roche's Xeloda Gets EC Approval
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... Continue Reading
Naproxen
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... Continue Reading
Feb 5
Newest Study Finds No Link Between MMR Vaccine and Autism
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... Continue Reading
FDA Grants Priority Review for Multiple Myeloma Drug Velcade
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... Continue Reading
Pancreatic Stem Cell Discovery Could Lead To Treatment of Type 1 Diabetes
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... Continue Reading
Asmanex Twisthaler from Schering Plough Gets FDA Approval
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... Continue Reading
Feb 4
Low Dose Recommended for Pregnant Women with Asthma
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... Continue Reading
FDA Concerned Over Lilly's Zyprexa Adhera
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... Continue Reading
Chantix Early Communication Become FDA Warning
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... Continue Reading
Recalled Heparin Causes Allergic Reaction in Dialysis Patients
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... Continue Reading
Feb 1
Interesting Articles for Week of February 1
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... Continue Reading
Stock Market Fluctuations in Big Pharmas as of February, 2008
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) -... Continue Reading
New Vaccine Prevents Getting “High”
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... Continue Reading
February is Heart Month - So Wear Red Today to Show Your Support
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... Continue Reading
Magnesium Sulfate May Cut the Risk of Cerebral Palsy?
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... Continue Reading
Invisible ‘gel condom’ works to protect from HIV?
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... Continue Reading
Epilepsy Drugs To Get FDA Warning
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... Continue Reading

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