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Table 2 Sensitivity, specificity, positive predictive value and negative predictive value of IFOBT for cancer and large adenoma Sensitivity Cancer 95% CI ; Large adenoma adenoma 10 mm ; 95% CI ; 52.6% 30.175.1 ; 24.5% 12.936.1 ; Specificity 87.2% 86.088.4 ; 87.1% 85.988.3 ; Positive predictive Negative predictive value value 2.5% 1.04.0 ; 3.2% 1.54.9 ; 99.7% 97.599.9 ; 98.5% 98.099.0, for example, pregnancy.
ADVERSE REACTIONS Adverse events were assessed in eight placebo-controlled clinical trials involving 2274 patients exposed to either 50 or 100 mg b.i.d. PLETAL n 1301 ; or placebo n 973 ; , with a median treatment duration of 127 days for patients on PLETAL and 134 days for patients on placebo. The only adverse event resulting in discontinuation of therapy in 3% of patients treated with PLETAL 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with PLETAL 50 mg b.i.d., 100 mg b.i.d, or placebo, respectively. Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol all doses ; versus 0.1% for placebo. The most commonly reported adverse events, occurring in 2% of patients treated with PLETAL 50 or 100 mg b.i.d., are shown in the table below ; . Other events seen with an incidence of 2%, but occurring in the placebo group at least as frequently as in the 100 mg b.i.d. group were: asthenia, hypertension, vomiting, leg cramps, hypesthesia, paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis, and bronchitis.
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License and Distribution Agreements Rights to market Defibrotide for different indications are shared between two companies based on geography. Crinos, a subsidiary of Stada Arneimittel AG, has marketing rights for Defibrotide in its only approved market, which is the prevention and treatment of vascular disease with risk of thrombosis in Italy, and the right of first refusal for this and other uses approved going forward in all European countries. In the Americas, Gentium has licensed rights for the treatment of VOD to Sigma-Tau Pharmaceuticals, which also has the right of first refusal for VOD prophylaxis and stem cell mobilization if Gentium chooses to partner these programs. Details of these agreements as depicted in Figure 5 ; are provided below and propranolol, because ticlid.
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Companies in the 21st century face completely different challenges from those in the 20th century. Pharmaceutical companies have been traditionally organized with research and development, manufacturing, marketing and management functions. Companies must now also be covered by two additional nerve-like systems, namely a "stakeholder system" and a "compliance system." Both these systems serve as conduits for the exchange of information and messages. Daily operation and decision-making should respect the governance by the two systems in reference to two criteria: "Does the decision support the benefit of the shareholders?" and "Does the decision comply with regulations?" It is vital for companies today to develop these two systems to ensure survival. Another recent important trend is the supply of pharmaceuticals to socially and economically disadvantaged people. A typical example is the access to AIDS drug treatment in Africa. This is a major issue involving compulsory licenses for patents, and has been a major focus of the World Trade Organization. In the United States, the Bush Administration has proposed a Medicare prescription drug benefit which requires funding of about $400 billion over a 10-year period. That would also be an access issue to drug treatment for the elderly, in a broad sense. At the same time, we are witnessing efforts to allow cross-border trading of drugs within the European Union and to enable the re-importation of drugs into the United States. We are acutely aware of the significance of such trends when managing our business. At Eisai, we aim to manage our Company through vision-led operations. Our vision is to give first thought to patients and their families, and to increasing the benefits health care provides. Our goal is to conduct all of our operations, from the research and development stage onwards, with this vision in mind. We believe that the effective and efficient realization of this goal will contribute to better results in sales and profits. In this sense, we consider our vision to be of equal importance to achieving operational results. Our continuous challenge is how to realize this vision by our 7, 000 employees worldwide. We are working across the Company to connect directly with patients and their communities, through what we call "knowledge creation projects." I pleased to report that we have 996 such projects in process globally. Many of our employees have direct involvement with patients and their communities and are gaining valuable knowledge through their daily activities.
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Table 2. Effects of 4-aminopyridine and tetraethylammonium on isometric contraction and half-relaxation times of the diaphragm, extensor digitorum longus and soleus muscles. Contraction Time ms ; Extensor Digitorum Longus 12.7 0.7 14.4 Half-Relaxation Time ms ; Extensor Digitorum Longus 10.4 0.9 12.6.
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New Members New members in our plan may be taking drugs that are not on our formulary, or that are subject to certain restrictions, such as prior authorization. In instances like these, you need to talk with your doctor about appropriate alternative therapies available on our formulary. If there are no appropriate alternative therapies on our formulary, you or your doctor can request a formulary exception which is a type of coverage determination ; in order to get coverage for the drug. See Section 6 Appeals and Grievance: What to do if you have complaints ; to learn more about how to request an exception. If the exception is approved, you will be able to obtain the drug you are taking for a specified period of time. While you are talking with your doctor to determine your course of action, you may be eligible to receive an initial 30-day transition supply of the drug anytime during the first 90 days you are a member of our plan. For each of the drugs that is not on our formulary or that have coverage restrictions or limits, we will cover a temporary 30-day supply unless you have a prescription written for fewer days ; when you go to a network pharmacy. After your first 30-day supply, we will not continue to pay for these drugs under the transition policy, even if you have been a member of our plan less than 90 days. If you are a resident of a long-term care facility, we will cover a temporary 31-day transition supply unless you have a prescription written for fewer days ; . We will cover more than one refill of these drugs provided the total amount filled during the first 90 days you are a member of our plan does not exceed 93 days supply. If you need a drug that is not on our formulary or subject to other restrictions, such as prior authorization or dosage limits, but you are past the first 90 days of membership in our plan, we will cover a 31-day emergency supply of that drug unless you have a prescription for fewer days ; while you pursue a formulary exception. If you are outside the transition period and experiencing circumstances that involve a level of care change where you must change from one treatment setting to another, we will cover a temporary 31-day transition supply unless you have a prescription written for fewer days ; while you pursue a formulary exception and ramipril.
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Come in 2003 was related to the settlement with GlaxoSmithKline that resulted in the receipt of Purinethol product rights. Taking these factors into account, net income in 2004 decreased 52% to $331.8 million compared with 2003, and fully diluted earnings per American Depositary Receipt were 50 cents, down 56.9% compared with 2003. Excluding these amounts, net income grew 56% in 2004 to $964.6 million, and fully diluted earnings per American Depositary Receipt were $1.42 in 2004. In the first six months of 2005, Teva recorded $2.53 billion in net sales, 13.6% more than in first-half 2004. Net income amounted to $500.3 million for the first half of this year, compared with a loss of $198.5 million during the same period in 2004. Teva's diluted earnings per American Depositary Receipt were reported to be 74 cents in the first six months of 2005, compared with a loss per share of 33 cents in first-half 2004. North American sales in 2004 reached $3.06 billion, up 48.9% compared with 2003. Teva Pharmaceuticals USA markets about 220 generic products representing about 600 dosage strengths and packaging sizes. The 30 new generic products that were introduced in the United States in 2004 contributed to the sales growth. These products included generic versions of Floxin, Lotensin, Wellbutrin SR, Buspar, Zaroxolyn, OxyContin, Ortho Cyclen-28, Ortho Tri-Cyclen, Zebeta, Fludara, Zyban, Cipro, Adenocard, Glucophage XR, Brethine, Paraplatin, Diflucan, Prilosec, Depo-Provera, Augmentin ES, Betapace AF, Rebetol, Neurontin, Romazicon, Pletal, Ceftin, and Accupril. In the first six months of 2005, Teva generated about $1.49 billion in sales of pharmaceutical products in North America, a 5.2% increase compared with first-half 2004. Teva experienced significantly higher European sales of generic products in 2004, resulting from new product launches and favorable currency trends. European sales in 2004 reached $1.25 billion, up 44.6% compared with 2003. Among the significant products introduced in Europe during 2003 and 2004 were generic versions of Neurontin, Zocor, Losec, Tritace, and Lipostat. In the first half of 2005, Teva generated $749 million in sales in Europe, growth of 29.8% compared with the first half of 2004. Pharmaceutical sales in Israel amounted to $263 million in 2004, an increase of 8% compared with 2003. Teva is the largest nongovernmental supplier of healthcare products and services in Israel, which has a market for pharmaceuticals of about and rivastigmine and pletal.
10. Macrobid 11. Mestinon 12. Monopril 13. Neurontin 14. Ortho Tri-Cyclen 15. Ortho-Cyclen 16. OrthoNovum7 7 17. OxyContin 18. Paraplatin 19. Paxil 20. Pleral 21. Rebetol 22. Remeron SolTab 23. Salagen 24. Tambocor 25. Terazol 3 26. Wellbutrin SR 27. Zyban.
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