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Etoricoxib bioequivalence fda approval status number approved fda time frame (years) action summary FDA actions in connection with approval FDA history Final in the U.S. FDA Approvals by Type A. FDA approval approvals of anticancer agents: Abiraterone for patients with the following indications: 1. Pending approval for the administration of abiraterone to adults with metastatic cancer of the colon, rectum, and prostate (see §4.1 for a description of the approved indication); 2. Faced with shortage of abiraterone during 2005, the National Cancer Institute granted priority review for abiraterone patients with metastatic cancer of other organs; 3. Faced with shortage of abiraterone during the period 2000-2005, National Cancer Institute granted priority review to abiraterone for patients with Over the counter drug that looks like xanax who are terminally ill, or patients who may potentially benefit from abiraterone (see §4.3 for a description of the approved indication); 4. Faced with shortage of abiraterone during the period 2001-2003, National Cancer Institute assigned priority review to ibudilast for the treatment of metastatic breast cancer (see §4.6); 5. Faced with shortage of ibudilast during the period 2000-2003, National Cancer Institute gave priority review to lomustine for the treatment of metastatic gastric cancer (see §4.10(e)). For more information, see the FDA news release on approval of ibudilast for metastatic gastric cancer. Abiraterone was also evaluated in patients with a history of systemic lupus erythematosus (SLE) for the treatment of lupus-related symptoms and signs. The sponsor reported that results of the study have not met minimum criteria to buy xanax in australia move forward the second round of this Phase III clinical trial at its request. SLE clinical trials are being conducted under the investigational new drug authorization program administered by the Agency for Health Care Research and Quality. The company intends to conduct a similar and separate clinical trial in 2011. SLE trials are also being conducted at sites in the U.S, and Europe (see http://www.acure.com/index.aspx?id=2&cid=12 ). In September, 2004, the FDA approved mitoxantrone orally, intramuscular, or parenteral, for the treatment of patients with metastatic, hematologic, or solid cancers of the lungs, colon, rectum, stomach, and prostate who have failed prior therapy to improve their symptoms. Mitoxantrone was approved for the same indications by FDA in January 2005, and is currently used in about 5,300 cases, the United States, and internationally, according to the Merck Pharmaceuticals website. In January 2005, the FDA gave its preliminary OK to the first and, for about 2 years, only, FDA approved the use of mitoxantrone for treatment patients with liver cancer, or any solid tumours that have spread to adjacent areas or are present on liver cancer tissue biopsied for testing. At the recommendation of FDA's oncologists, Merck conducted a Phase II trial in about 2,300 patients who had undergone radical liver surgery and received two doses of mitoxantrone, either as monotherapy or in combination with an antitumor drug. After two months of treatment, about one third the patients developed a tumour, and most of it responded to the treatment within three months after the first dose. Merck also evaluated mitoxantrone with chemotherapy in about 7,450 patients with glioblastoma multiforme (GBM), a rare type of brain cancer. The company conducted trial from November to April, 2004, and reported the results in September 2006. After two-and-a-half months of treatment, about half the patients exhibited a response. After three months of treatment, about one third the patients had complete responses. For this second Phase II trial, Merck is planning to run it in the U.S. until at least September 2008. The company plans to conduct third Phase II trial, evaluating mitoxantrone together with chemotherapy for about 2,500 patients over a six-year period. A Phase II trial evaluated the effect of mitoxantrone alone and in combination with cyclophosphamide patients advanced glioblastoma. A second Phase II trial (NCT01162701) evaluating mitoxantrone alone with cyclophosphamide evaluated the combination paclitaxel in patients with advanced glioblastoma. Treatment with mitoxantrone orally in patients Is lorazepam generic for xanax treated with high dose cyclophosphamide for the treatment where to buy xanax in sydney of malignant gliomas has not yet.
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