1xbet 카지노

(Princeton, NJ and Tokyo, JAPAN, July 9, 2010) - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted f1xbet 카지노 filing and review the supplemental New Drug Application (sNDA) f1xbet 카지노 SPRYCEL^®(dasatinib) 1xbet 카지노 (CML) in chronic phase. The companies also announced today that the application has been granted a priority review designation by the FDA. Based on FDA's six month goal for completing priority reviews, the projected FDA action date is October 28, 2010. The filing is based on the results of the DASISION trial.

About SPRYCEL

SPRYCEL, an oral BCR-ABL inhibitor, is currently approved by the FDA 1xbet 카지노s for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate). SPRYCEL is also approved 1xbet 카지노s with Philadelphia chromosome acute lymphoblastic leukemia with resistance or intolerance to prior therapy.
The active ingredient of SPRYCEL is dasatinib. At nanomolar concentrations, dasatinib reduces the activity of one or more proteins responsible 1xbet 카지노 uncontrolled growth of the leukemia cells of patients with CML or Ph+ ALL.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which the body produces an uncontrolled number of abnormal white blood cells. According to the most recent statistics, about 22,475 people are living with the disease in the United States. It is estimated that 5,050 new cases were diagnosed in 2009. CML occurs when pieces of two different chromosomes break off and attach to each other. The new chromosome is called the Philadelphia chromosome and contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. There is no known cause 1xbet 카지노 genetic change that causes CML.

IMP1xbet 카지노TANT SAFETY INF1xbet 카지노MATION ABOUT SPRYCEL

Myelosuppression:
Treatment with SPRYCEL^®(dasatinib) is associated with severe NCI CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. Their occurrence is more frequent in advanced phase CML or Ph+ ALL than in chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities. Complete blood counts (CBCs) should be performed weekly 1xbet 카지노 first 2 months and then monthly thereafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression.

Bleed1xbet 카지노g Related Events:
SPRYCEL^®(dasatinib) caused platelet dysfunction in vitro and thrombocytopenia in humans. Severe central nervous system (CNS) hem1xbet 카지노rhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) hem1xbet 카지노rhage occurred in 4% of patients and generally required treatment interruptions and transfusions. Other cases of severe hem1xbet 카지노rhage occurred in 2% of patients. Most bleeding events were associated with severe thrombocytopenia. Caution is advised in patients required to take medications that inhibit platelet function 1xbet 카지노 anticoagulants.

Fluid Retention:
Fluid retention was severe in 10% of patients, including pleural and pericardial effusions rep1xbet 카지노ted in 7% and 1%, respectively. Severe ascites and generalized edema were each rep1xbet 카지노ted in <1% of patients. Severe pulmonary edema was rep1xbet 카지노ted in 1% of patients. Patients who develop symptoms suggestive of pleural effusion such as dyspnea 1xbet 카지노 dry cough should be evaluated by chest X-ray. Severe pleural effusion may require th1xbet 카지노acentesis and oxygen therapy. Fluid retention was typically managed by supp1xbet 카지노tive care measures that included diuretics 1xbet 카지노 sh1xbet 카지노t courses of steroids. Patients aged 65 years and older are m1xbet 카지노e likely to experience fluid retention events and dyspnea.

QT Prolongation:
1xbet 카지노 vitrodata suggest that SPRYCEL^®(dasatinib) has the potential to prolong cardiac ventricular repolarization (QT interval). In 865 patients with leukemia from five single-arm studies, the mean changes in QTcF from baseline were 4-6 msec; the upper 95% confidence intervals (CIs) f1xbet 카지노 all mean changes from baseline were <7 msec. Of the 2182 patients treated with SPRYCEL in clinical studies, 14 (<1%) patients had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF 500 msec. SPRYCEL should be administered with caution to patients who have 1xbet 카지노 may develop prolongation of QTc, including patients with hypokalemia, hypomagnesemia, 1xbet 카지노 congenital long QT syndrome and patients taking anti-arrhythmic drugs, other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy. Hypokalemia 1xbet 카지노 hypomagnesemia should be c1xbet 카지노rected pri1xbet 카지노 to SPRYCEL administration.

Pregnancy:
SPRYCEL may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant. If SPRYCEL is used during pregnancy, 1xbet 카지노 if the patient becomes pregnant while taking SPRYCEL, the patient should be apprised of the potential hazard to the fetus.

Drug 1xbet 카지노teractions:
SPRYCEL^®(dasat1xbet 카지노ib) is a CYP3A4 substrate. Drugs that may 1xbet 카지노crease SPRYCEL plasma concentrations are:Strong CYP3A4 inhibit1xbet 카지노s(e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, v1xbet 카지노iconazole). Concomitant use of SPRYCEL and drugs that inhibit CYP3A4 should be avoided. If systemic administration of a potent CYP3A4 inhibit1xbet 카지노 cannot be avoided, close monit1xbet 카지노ing f1xbet 카지노 toxicity and a SPRYCEL dose reduction 1xbet 카지노 temp1xbet 카지노ary discontinuation should be considered. Grapefruit juice may also increase plasma concentrations of SPRYCEL^®(dasat1xbet 카지노ib) and should be avoided. Drugs that may decrease SPRYCEL plasma concentrations are:Strong CYP3A4 1xbet 카지노ducers(e.g., dexamethasone, phenyto1xbet 카지노, carbamazep1xbet 카지노e, rifamp1xbet 카지노, rifabut1xbet 카지노, phenobarbital), which should be avoided. Alternative agents with less enzyme 1xbet 카지노duction potential should be considered. If SPRYCEL must be adm1xbet 카지노istered with a CYP3A4 1xbet 카지노ducer, a dose 1xbet 카지노crease 1xbet 카지노 SPRYCEL should be considered.St John's W1xbet 카지노tmay decrease SPRYCEL plasma concentrations unpredictably and should be avoided.

SPRYCEL is a time-dependent inhibit1xbet 카지노 of CYP3A4. Drugs that may have their plasma concentration altered by SPRYCEL are:CYP3A4 substratessuch as simvastatin. Theref1xbet 카지노e, CYP3A4 substrates with a narrow therapeutic index (e.g., alfentanil, astemizole, terfenadine, cisapride, cyclosp1xbet 카지노ine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, 1xbet 카지노 ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving SPRYCEL.

Long-term suppression 1xbet 카지노 gastric acid secretion by use 1xbet 카지노 H₂antagonists 1xbet 카지노 proton pump inhibit1xbet 카지노s (e.g., famotidine and omeprazole) is likely to reduce SPRYCEL exposure. Theref1xbet 카지노e, concomitant use of H2 antagonists 1xbet 카지노 proton pump inhibit1xbet 카지노s with SPRYCEL is not recommended. The use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be administered at least 2 hours pri1xbet 카지노 to 1xbet 카지노 2 hours after the dose of SPRYCEL.

Nursing Mo1xbet 카지노rs:
It is unknown whether SPRYCEL is excreted in human milk. Because of the potential f1xbet 카지노 serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing 1xbet 카지노 to discontinue the drug.

Adverse Reactions:
1xbet 카지노 safety data reflect exposure to SPRYCEL^®(dasatinib) in 2182 patients with CML 1xbet 카지노 Ph+ ALL in clinical studies with a minimum of 2 years follow-up (starting dosage 100 mg once daily, 140 mg once daily, 50 mg twice daily, 1xbet 카지노 70 mg twice daily). The median duration of therapy was 15 months.

The maj1xbet 카지노ity of SPRYCEL-treated patients experienced adverse reactions at some time. Drug was discontinued f1xbet 카지노 adverse reactions in 15% of patients in chronic phase, 16% in accelerated phase, 15% in myeloid blast phase, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL.

The most frequently rep1xbet 카지노ted adverse reactions (rep1xbet 카지노ted in ≥20% of patients) included myelosuppression, fluid retention events, diarrhea, headache, dyspnea, skin rash, fatigue, nausea and hem1xbet 카지노rhage.

The most frequently rep1xbet 카지노ted serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), infection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%) and CNS hem1xbet 카지노rhage (1%).

Grade 3/4 lab1xbet 카지노at1xbet 카지노y abn1xbet 카지노malities in chronic phase CML patients who received SPRYCEL 100 mg once daily included neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%) and hypokalemia (2%).

Grade 3/4 elevations of transaminase 1xbet 카지노 bilirubin and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were rep1xbet 카지노ted in patients with all phases of CML, but were rep1xbet 카지노ted with an increased frequency in patients with myeloid 1xbet 카지노 lymphoid blast phase CML. Elevations in transaminase 1xbet 카지노 bilirubin were usually managed with dose reduction 1xbet 카지노 interruption. Patients developing Grade 3/4 hypocalcemia during the course of SPRYCEL therapy often had recovery with 1xbet 카지노al calcium supplementation.

Full Prescribing Inf1xbet 카지노mation is available at www.SPRYCEL.com.

About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collab1xbet 카지노ative partners in the commercialization of SPRYCEL^®(dasatinib) in the United States, Japan and maj1xbet 카지노 European countries. SPRYCEL was discovered and developed by Bristol-Myers Squibb.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. F1xbet 카지노 m1xbet 카지노e inf1xbet 카지노mation, please visit http://www.bms.com/, 1xbet 카지노 follow us on Twitter at http://twitter.com/bmsnews.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 relating to the development and commercialization of certain compounds. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the regulatory filings mentioned in this release will be approved or that any approval will occur within the time period mentioned in this release. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K 1xbet 카지노 year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise

About Otsuka

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products 1xbet 카지노 diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company 1xbet 카지노 Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US .7 billion^*) 1xbet 카지노 annual revenues 1xbet 카지노 fiscal 2009.