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All GLG News Analyses Filed Under: Cardiology

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Posted August 30, 2007
Xyzal approval
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: Mitchell Boxer, Assistant Clinical Professor Albert Einstein College of Medicine
Zyrtec will soon be available over the counter and this new product will attempt to keep the antihistamine market share for Sanofi-Aventis - although Zyrtec is presently manufactured by Pfizer.  The antihistamine market is quite large and the OTC versus prescription situation is making this problematic...
Posted August 28, 2007
Angio-seal today-SS
Analysis of: St. Jude Medical Announces Japanese Approval Of The Angio-Seal STS Plus Vascular Closure Device | www.medicalnewstoday.com
Author: GLG Member Program Contributor
The key implications remain 1)Safety 2)Efficacy 3)Cost 4)Complications e)Outcome analysis
Posted August 28, 2007
FDA Review of Proton Pump Inhibitors (PPI's)
Analysis of: Survey: Did the FDA Jump the Gun on PPIs? | www.medpagetoday.com
Author: GLG Member Program Contributor
The frequency of proton pump inhibitors (PPI) prescriptions make FDA review an important step in the long-term assessments of their risk-benefit profile.  It is important to recognize that the FDA did not change the prescribing indications or even issue a warning to physicians about the use of...
Posted August 28, 2007
The drug patent "shell game"
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: Forrest Rubenstein, Cardiac, Thoracic and Vascular Surgeon Rubenstein Cardiovascular and Thoracic Surgery
   Zyrtec (cetirizine) is a second generation nonsedating antihistamine that has enjoyed wide popularity.  Zyrtec will become available generically in late 2007 and the generic form is expected to be significantly cheaper.  To virtually extend the patent, the manufacturer is...
Posted August 27, 2007
Xyzal is a more or less unnecessary drug being added to a saturated market
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: GLG Member Program Contributor
Levocetirizine has been approved by the FDA for treatment of allergic rhinitis and other allergic manifestations (e.g., urticaria), which means that there is yet another anti-histamine on the market with similar efficacy as already-approved anti-histamines, and yet another drug of minor (if any) marginal...
Posted August 27, 2007
Ateempt at End Run Around Patent Expiration Will Likely Fail
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: GLG Member Program Contributor
- this drug is an attempt to avoid loss of revenue when Zyrtec goes   generic in the third quarter of 2007.  - as it will be more expensive, and no more effective than generic    Zyrtec, it will likely fail
Posted August 27, 2007
Better?
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: GLG Member Program Contributor
The side effect profile of zyrtec and xyzal apppear mostly similar. It is unclear what this will add to a market where generics are already in place that are nonsedating.
Posted August 27, 2007
Xyzal: wait and watch before adoption.
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: GLG Member Program Contributor
Adverse effects on kidney and liver. Degree of sedation. Incidence of epistaxis.
Posted August 27, 2007
Another Chiral Medication Without Significant Benefit
Analysis of: New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com
Author: GLG Member Program Contributor
Levocertirizine is the active enantiomer of the well-known antihistamine Zyrtec. Both Zyrtic and Xyzal, undergo a rapid and complete uptake in the GI tract and then metabolized to a very limited extent and have a high renal clearance. Xyzal does not have any advantage over Zyrtec
Posted August 21, 2007
FIRE STAR™ Rx PTCA Dilatation Catheter - an incremental improvement, not disruptive technology
Analysis of: Cordis Corporation Introduces FIRE STAR™ Rx PTCA Dilatation Catheter | www.medicalnewstoday.com
Author: Forrest Rubenstein, Cardiac, Thoracic and Vascular Surgeon Rubenstein Cardiovascular and Thoracic Surgery
   Cordis introduced the FIRE STAR™ Rx PTCA Dilatation Catheter to the European market.  This catheter reportedly has a lower profile than other devices on the market which enables it to cross highly stenotic or tortuous lesions.  There are no controlled studies showing device...
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