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In separate meetings held October 19 and 20, FDA's Nonprescription Drugs Advisory Committee NDAC ; met to consider the safety of phenylpropanolamine PPA ; and the switch application for Orilosec 1, respectively. PPA After five hours of presentations and discussions regarding PPA and the Yale Hemorrhagic Stroke Project HSP ; , NDAC voted that PPA should not be considered "generally recognized as safe" for use as a decongestant nor as an appetite suppressant. Epidemiologist, Janet Daling, Ph.D., of the Fred Hutchinson Cancer Research Center in Seattle, Washington, abstained from voting, citing the limitations of the Yale study in being able to control for confounding factors. Other leading U.S. experts in attendance also questioned the methodology employed by the study and pointed to a number of flaws in the research. Epidemiologists Charles H. Hennekens, M.D., University of Miami School of Medicine; Noel Weiss, M.D., University of Washington; Lewis H. Kuller, M.D., University of Pittsburgh School of Health; and Robert B. Wallace, M.D., University of Iowa Colleges of Public Health and Medicine; and neurologist Philip B. Gorelick, M.D., Rush Medical College, all provided expert opinion at the meeting questioning the Yale team's interpretation of results. CHPA presentations underscored the following key points: There are too few cases and controls in the Yale study that took PPA to allow for effective control of confounding factors. Cases had significantly greater independent risk factors for stroke than controls. The core analysis of appetite suppressant use by women was based on six PPA-exposed cases and one PPA-exposed control, a number too small to permit control for confounding by independent risk factors.
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The Tiffany catalog. The distinctive color is an important cognitive touch-point of her user experience that eventually triggers the purchase of an expensive luxury item read enormous profit margin ; . I submit that the robin'segg blue is an important design element in the overall commercial success of Tiffany & Co. But if the color design attribute is so important to the user experience, why don't other companies emulate it? It turns out that the use of the robin's-egg blue on boxes, package wrappings, shopping bags and even catalogs is the monopoly right of Tiffany & Co. with four separate registered trademarks ; . Again, for emphasis: Tiffany & Co. has a legal monopoly on the use of robin's-egg blue on packaging, bagging and the cover of its catalog. This finding led me to begin exploring to what extent color and other relatively primitive elements of design can be secured indefinitely with a registered US trademark? Color Me Profitable The color purple in the market for gastrointestinal medications may not seem important unless you suffer from chronic heartburn. If you do, you know that the purple pill means Prilosed or its more recent embodiment, Nexium. This drug is a record-breaking blockbuster that earns as much as $6 billion a year for AstraZeneca Inc. AZ ; . The color purple is the cognitive touch-point that gives hope for relief from painful heartburn. The color purple as used on AZ's pills and packaging is a registered trademark. The patent on the Priloxec compound expired in 2001, and generics and the corresponding price competition entered the market soon thereafter. But by carefully guiding the brand-loyal market segment from Orilosec to Nexium in its advertising and the use of purple, AZ has sustained its $6 billion dollar revenue stream through 2005, four years after the original patent expiration. In the housing market, Owens Corning's registered trademark color pink triggers an association of quality and efficiency among those looking for insulation materials. Its widespread recognition is the result of a carefully orchestrated advertising campaign, with Pink Panther commercials and a "think pink" tagline, that built a significant association between pink and high-quality insulation. A trip to Home Depot demonstrates that the pink stuff costs appreciably more than a non-pink alternative. In the market for mobile telephone materials, the color magenta is the unique source identifier registered trademark ; of T-Mobile and its parent Deutsche Telekom. When branding giant Intel overlooked the breath of this mark and errantly introduced magenta into the Centrino logo for mobile technology, DT responded with an army lawyers. Intel quietly retreated to another color. Brown in transportation and marketing logistics is the domain of UPS and is a registered trademark on trucks and uniforms. Is it any surprise that UPS's advertising calls on consumers to "call brown" for supply chain challenges?.
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I hope to get laws changed so that the social terrorism caused by mixing up powerful medications on purpose is no longer legal; that full disclosure of the chemical makeup of all medications sold in america be required; that drug manufactures be stripped of their legal protections regarding intellectual property rights - because people's lives are at stake; and that a federally funded medication education campaign be started that fully educates all americans of all the problems, horrors, side-effects, and effective properties of name brand and generic drugs and ranitidine.
34% to $730 million. Sales in other markets increased by 41%. Seloken sales increased by 24% to $1, 733 million, and together with Crestor, offset declines in Zestril and Plendil. Oncology sales grew by 12% to $3, 845 million driven by a 44% increase in Arimidex. Casodex grew by 10% to $1, 123 million whilst Zoladex sales exceeded $1 billion for the first time. Iressa sales fell by 31% to $273 million. Neuroscience also saw significant growth driven by Seroquel sales which increased by 15% to $2, 761 million up 35% ; . Respiratory and Inflammation sales increased by 9% to $2, 873 million with Symbicort up 22% to $1, 006 million ; the principal driver. Geographic analysis Underlying sales growth in the US was 12%. However, growth was estimated to be 10% when adjusted for net wholesaler inventory movements in 2003 and 2004. Increased sales of Crestor, Seroquel, Nexium and Arimidex more than offset a further $102 million decline in sales of Prilosec. Inventory movements were neutral following the successful introduction of Distribution Service Agreements. Adjustments to prior year managed care accruals benefited US sales growth by 2.
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6a Evidence Based Reviews The first step in evaluating a therapeutic class of medications for the PDL is the evidence based review. The Department of Health has joined a consortium of states known as the Drug Effectiveness Review Project DERP ; , administered through Oregon Health & Sciences University's OHSU ; Center for Evidence Based Policy. DERP utilizes Evidence Based Practice Centers EPCs ; located around the country to complete a thorough evaluation and review of the best available evidential literature on safety and effectiveness of the most widely used classes of prescription drugs. Wyoming established a Preferred Drug List Advisory Committee PDLAC ; made up of physicians, pharmacists, other insurers and a consumer representative. The committee reviews the evidence based report from the Oregon DERP project on a therapeutic class and makes recommendations to the Department of Health regarding safety and effectiveness. Cost is not considered during the evidence based review process. 6b Evaluation of Cost The Department of Health takes the recommendation of the PDLAC and chooses one or more preferred medications within a therapeutic class based on unit cost, net of rebate. This means that the "preferred" medication s ; will not require any special authorization. It should be noted that rebate is absolutely critical to this step in the process as it can greatly shift the cost for a class. Below is a table that shows the proton pump inhibitors PPI ; from lowest cost to highest cost before and after factoring in rebate. PPI Cost Before Rebate lowest cost to highest cost ; Prilosec OTC Omeprazole generic Prilosec ; Protonix Nexium Aciphex Prevacid Prilosec 6c Prior Authorization Criteria Medications which are not chosen as preferred medications remain available to Medicaid clients through prior authorization. This is a federal requirement tied to the open formulary mandate for Medicaid. The Drug Utilization Review DUR ; Board consisting of statewide physicians and pharmacists ; research and recommend criteria for the nonpreferred medications to the Department. When criteria for a new therapeutic class are applied, providers are notified and federal regulations are adhered to. A complete and accurate prior authorization request must be either authorized or denied within 24 hours, or a 72 hour emergency supply is available for holidays and weekends, per federal PPI Cost After Rebate lowest cost to highest cost ; Prilosec OTC Protonix Prevacid Aciphex Nexium Omeprazole generic Prilosec ; Prilosec.
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