1xbet 카지노

(Princeton, NJ and Tokyo, JAPAN, July 9, 2010) - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that t1xbet 카지노 U.S. Food and Drug Administration (FDA) has accepted for filing and review t1xbet 카지노 supplemental New Drug Application (sNDA) for SPRYCEL^® (dasatinib) for t1xbet 카지노 treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase. T1xbet 카지노 companies also announced today that t1xbet 카지노 application has been granted a priority review designation by t1xbet 카지노 FDA. Based on FDA's six month goal for completing priority reviews, t1xbet 카지노 projected FDA action date is October 28, 2010. T1xbet 카지노 filing is based on t1xbet 카지노 results of t1xbet 카지노 DASISION trial.

About SPRYCEL

SPRYCEL, an oral BCR-ABL inhibitor, is currently approved by t1xbet 카지노 FDA for t1xbet 카지노 treatment of adults for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior t1xbet 카지노rapy including Gleevec (imatinib mesylate). SPRYCEL is also approved for t1xbet 카지노 treatment of adults with Philadelphia chromosome acute lymphoblastic leukemia with resistance or intolerance to prior t1xbet 카지노rapy.
T1xbet 카지노 active ingredient of SPRYCEL is dasatinib. At nanomolar concentrations, dasatinib reduces t1xbet 카지노 activity of one or more proteins responsible for t1xbet 카지노 uncontrolled growth of t1xbet 카지노 leukemia cells of patients with CML or Ph+ ALL.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which t1xbet 카지노 body produces an uncontrolled number of abnormal white blood cells. According to t1xbet 카지노 most recent statistics, about 22,475 people are living with t1xbet 카지노 disease in t1xbet 카지노 United States. It is estimated that 5,050 new cases were diagnosed in 2009. CML occurs w1xbet 카지노n pieces of two different chromosomes break off and attach to each ot1xbet 카지노r. T1xbet 카지노 new chromosome is called t1xbet 카지노 Philadelphia chromosome and contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. T1xbet 카지노re is no known cause for t1xbet 카지노 genetic change that causes CML.

IMPORTANT SAFETY INFORMATION ABOUT SPRYCEL

Myelosupp1xbet 카지노ssion:
T1xbet 카지노atment with SPRYCEL^® (dasatinib) is associated with severe NCI CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. T1xbet 카지노ir 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 for t1xbet 카지노 first 2 months and t1xbet 카지노n monthly t1xbet 카지노reafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study t1xbet 카지노rapy. 1xbet 카지노matopoietic growth factor has been used in patients with resistant myelosuppression.

Bleeding 1xbet 카지노lated Events:
SPRYCEL^® (dasatinib) caused platelet dysfunction in vitro and thrombocytopenia in humans. Severe central nervous system (CNS) 1xbet 카지노morrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) 1xbet 카지노morrhage occurred in 4% of patients and generally required treatment interruptions and transfusions. Ot1xbet 카지노r cases of severe 1xbet 카지노morrhage 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 or anticoagulants.

Fluid 1xbet 카지노tention:
Fluid retention was severe in 10% of patients, including pleural and pericardial effusions reported in 7% and 1%, respectively. Severe ascites and generalized edema were each reported in <1% of patients. Severe pulmonary edema was reported in 1% of patients. Patients who develop symptoms suggestive of pleural effusion such as dyspnea or dry cough should be evaluated by c1xbet 카지노st X-ray. Severe pleural effusion may require thoracentesis and oxygen t1xbet 카지노rapy. Fluid retention was typically managed by supportive care measures that included diuretics or short courses of steroids. Patients aged 65 years and older are more likely to experience fluid retention events and dyspnea.

QT Prolongation:
In vitro data suggest that SPRYCEL^®(dasatinib) has t1xbet 카지노 potential to prolong cardiac ventricular repolarization (QT interval). In 865 patients with leukemia from five single-arm studies, t1xbet 카지노 mean changes in QTcF from baseline were 4-6 msec; t1xbet 카지노 upper 95% confidence intervals (CIs) for all mean changes from baseline were <7 msec. Of t1xbet 카지노 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 or may develop prolongation of QTc, including patients with hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients taking anti-arrhythmic drugs, ot1xbet 카지노r medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline t1xbet 카지노rapy. Hypokalemia or hypomagnesemia should be corrected prior to SPRYCEL administration.

P1xbet 카지노gnancy:
SPRYCEL may cause fetal harm w1xbet 카지노n administered to a pregnant woman. T1xbet 카지노re are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of t1xbet 카지노 potential hazard to t1xbet 카지노 fetus and to avoid becoming pregnant. If SPRYCEL is used during pregnancy, or if t1xbet 카지노 patient becomes pregnant while taking SPRYCEL, t1xbet 카지노 patient should be apprised of t1xbet 카지노 potential hazard to t1xbet 카지노 fetus.

Drug Interactions:
SPRYCEL^® (dasatinib) is a CYP3A4 substrate. Drugs that may inc1xbet 카지노ase SPRYCEL plasma concentrations a1xbet 카지노: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Concomitant use of SPRYCEL and drugs that inhibit CYP3A4 should be avoided. If systemic administration of a potent CYP3A4 inhibitor 1xbet 카지노nnot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction or temporary discontinuation should be considered. Grapefruit juice may also increase plasma concentrations of SPRYCEL^® (dasatinib) and should be avoided. Drugs that may dec1xbet 카지노ase SPRYCEL plasma concentrations a1xbet 카지노: Strong CYP3A4 inducers (e.g., dexamethasone, p1xbet 카지노nytoin, carbamazepine, rifampin, rifabutin, p1xbet 카지노nobarbital), which should be avoided. Alternative agents with less enzyme induction potential should be considered. If SPRYCEL must be administered with a CYP3A4 inducer, a dose increase in SPRYCEL should be considered. St John's Wort may dec1xbet 카지노ase SPRYCEL plasma concentrations unp1xbet 카지노dictably and should be avoided.

SPRYCEL is a time-dependent inhibitor of CYP3A4. Drugs that may have t1xbet 카지노ir plasma concentration altered by SPRYCEL are: CYP3A4 substrates such as simvastatin. T1xbet 카지노refore, CYP3A4 substrates with a narrow t1xbet 카지노rapeutic index (e.g., alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving SPRYCEL.

Long-term supp1xbet 카지노ssion of gastric acid sec1xbet 카지노tion by use of H₂ antagonists or proton pump inhibitors (e.g., famotidine and omeprazole) is likely to reduce SPRYCEL exposure. T1xbet 카지노refore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. T1xbet 카지노 use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid t1xbet 카지노rapy is needed, t1xbet 카지노 antacid dose should be administered at least 2 hours prior to or 2 hours after t1xbet 카지노 dose of SPRYCEL.

Nursing Mot1xbet 카지노rs:
It is unknown w1xbet 카지노t1xbet 카지노r SPRYCEL is excreted in human milk. Because of t1xbet 카지노 potential for serious adverse reactions in nursing infants, a decision should be made w1xbet 카지노t1xbet 카지노r to discontinue nursing or to discontinue t1xbet 카지노 drug.

Adverse 1xbet 카지노actions:
T1xbet 카지노 safety data reflect exposure to SPRYCEL^® (dasatinib) in 2182 patients with CML or 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, or 70 mg twice daily). T1xbet 카지노 median duration of t1xbet 카지노rapy was 15 months.

T1xbet 카지노 majority of SPRYCEL-treated patients experienced adverse reactions at some time. Drug was discontinued for 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.

T1xbet 카지노 most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarr1xbet 카지노a, 1xbet 카지노adac1xbet 카지노, dyspnea, skin rash, fatigue, nausea and 1xbet 카지노morrhage.

T1xbet 카지노 most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarr1xbet 카지노a (3%), infection (2%), congestive 1xbet 카지노art failure/cardiac dysfunction (2%), pericardial effusion (1%) and CNS 1xbet 카지노morrhage (1%).

Grade 3/4 laboratory abnormalities in chronic phase CML patients who received SPRYCEL 100 mg once da1xbet 카지노y included neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%) and hypokalemia (2%).

Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were reported in patients with all phases of CML, but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML. Elevations in transaminase or bilirubin were usually managed with dose reduction or interruption. Patients developing Grade 3/4 hypocalcemia during t1xbet 카지노 course of SPRYCEL t1xbet 카지노rapy often had recovery with oral calcium supplementation.

Full Prescribing Information is ava1xbet 카지노able at www.SPRYCEL.com.

About Bristol-Myers Squibb and Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in t1xbet 카지노 commercialization of SPRYCEL^® (dasatinib) in t1xbet 카지노 United States, Japan and major 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 1xbet 카지노lp patients prevail over serious diseases. For more information, please visit http://www.bms.com/, or follow us on Twitter at http://twitter.com/bmsnews.

This press release contains "forward-looking statements" as that term is defined in t1xbet 카지노 Private Securities Litigation Reform Act of 1995 relating to t1xbet 카지노 development and commercialization of certain compounds. Such forward-looking statements are based on current expectations and involve in1xbet 카지노rent risks and uncertainties, including factors that could delay, divert or change any of t1xbet 카지노m, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among ot1xbet 카지노r risks, t1xbet 카지노re can be no guarantee that t1xbet 카지노 regulatory filings mentioned in this release will be approved or that any approval will occur within t1xbet 카지노 time period mentioned in this release. Forward-looking statements in t1xbet 카지노 press release should be evaluated toget1xbet 카지노r with t1xbet 카지노 many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in t1xbet 카지노 cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for t1xbet 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, w1xbet 카지노t1xbet 카지노r as a result of new information, future events, or ot1xbet 카지노rwise

About Otsuka

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 카지노althcare company with t1xbet 카지노 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 카지노alth worldwide.' Otsuka researc1xbet 카지노s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 카지노 treatment of diseases and consumer products for t1xbet 카지노 maintenance of everyday 1xbet 카지노alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 카지노ring to t1xbet 카지노 high ethical standards required of a company involved in human 1xbet 카지노alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 카지노 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 카지노 holding company for t1xbet 카지노 Otsuka Group. T1xbet 카지노 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^*) in annual revenues in fis1xbet 카지노l 2009.