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 Wysłany: Nie 20:22, 20 Mar 2011 Temat postu: In 2003 several new drugs coming to market _166 |
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In 2003 several new drugs coming to market
City may eventually shake the Pfizer erectile dysfunction market advantage. But in the United States,[link widoczny dla zalogowanych], the FDA requested additional clinical pharmacology trials, tadalafil and vardenafil progress has been stopped, postponed a planned listing in 2002 in the U.S. plan. FDA cautious about the exact reasons are unclear, because in clinical trials,[link widoczny dla zalogowanych], these two products are no serious safety issues report. Moreover,[link widoczny dla zalogowanych], vardenafil the fact that the same was false, said proof of tadalafil had a long duration of action (approximately 24 hours) is hypocritical. In fact, and Viagra (Viagra) - like, Bayer products, the role of time and only 4 to 8 hours. 2. Cardiovascular In 2003, AstraZeneca will also launch a new The product is made good progress in Europe, in November received the first approval in the Netherlands. Expected to be listed in the Netherlands in early 2003 (according to the mutual recognition procedure will be approved in other markets in the EU). But Crestor in the U.S. but was delayed due to the FDA issued its June to approve the request to provide more data. AstraZeneca said they will be in Q1 of 2003 to provide additional information. Despite these setbacks, the company provides promising data,[link widoczny dla zalogowanych], Crestor dose range in all a lowering LDL cholesterol is more effective. The company has embarked on an ambitious clinical trial program, the program includes 80 000 patients, divided into 16 independent trials, in a wide range carried out by treatment. The test results obtained in 2003. In 2003, further progress will be another important new products, is AstraZeneca's cardiovascular drug Exanta (xime-lagatran). The product was in July 2002, under the mutual recognition procedure in the EU market without a name applied in a variety of selected orthopedic surgery for the prevention of venous thromboembolism (VTE), which is a series of possible indications in the first. The direct thrombin (thrombin) inhibitors are the first such products, is currently conducting a large-scale clinical trial program, which also includes for the prevention of stroke in patients with atrial fibrillation, and VTE treatment and secondary prevention. AstraZeneca plans to apply in the United States in 2003, hopes Exanta will be used in place of anticoagulant warfarin (warfarin) or heparin (heparin),[link widoczny dla zalogowanych], as Exanta oral administration and does not require a fixed surveillance to prevent clotting advantage. 3. Cancer 2003, might achieve some interesting tumor development, including ImCloneSystems / Bristol-MyersSquibb's Erbitux (cetuximab), the product for the treatment of irinotecan (irinotecan)-resistant colon cancer. The epidermal growth factor inhibitors is insider stock trading scandal in 2002 the focus of scandal in late 2001, the FDA refused to accept the product Biologic License Application (BLA) and triggered. While ImClone subsequently fall into all kinds of legal difficulties, Erbitux is still seen as promising. By the European partners MerckKgaA nl conducted clinical trial, planned for Q1 2003 report the results of this trial will support the re-make of the product BLA. In addition, Erbitux in other cancer patients carried out by the new test has begun. Another anti-cancer drug is licensed ~ Glaxo-SmithKline Corixa's Bexxar (I a 131tositumoomab), also appears ready to make a final listing, although the indications are limited to the relatively narrow. In December 2002, at a meeting on the product, the U.S. FDA Oncology Drug Advisory Committee voted in favor of approval of this product for chemotherapy and rituximab-resistant non-Hodgkin's lymphoma (NHL). The product was first applied in 1999, have been waiting for years, in 2002 and dragged late. Scheduled to be held in February 2003 an expert panel discussion
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