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米国で承認済みで日本で未承認の医薬品について
| No. | 国名 | 有効成分名 | 企業名 | 承認日 | 効能・効果 | 調査日 |
|---|---|---|---|---|---|---|
| 1 | アメリカ | ARTEMETHER/ LUMEFANTRINE | NOVARTIS | 2009/4/7 | ・Coartem (artemether and lumefantrine) Tablets are indicated for treatment of acute, uncomplicated malaria infections duc to Plasmodium falciparum in patients of 5 kg bodyweight and above (1) ・ Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has becn reported (I) . ・Coartem Tablets should not be used to treat severe malaria or to prevent malaria (1) |
2013/9/10 |
| 2 | アメリカ | BENZYL ALCOHOL | SHIONOGI INC | 2009/4/9 | TRADENAME*I) Lotion is a pediculocide indicated for the topical treatment of head lice infestation in patients 6 months of age and older. (1.1) TRADENAME Lotion does not have ovocidal activity. (1.2) |
2013/9/10 |
| 3 | アメリカ | abobotulinumtoxinA*II) | IPSEN BIOPHARM LTD | 2009/4/29 | DYSPORT™ is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: · the treatment of adults with cervical dystonia to reduce the severity of abnonnal head position and neck pain in both toxin-naïve and previously treated patients (1.1) · the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients < 65 years of age (1.2) |
2013/9/10 |
| 4 | アメリカ | ILOPERIDONE | NOVARTIS | 2009/5/6 | FANAPT is an atypical antipsychotic agent indicated for the acute treatment of schizophrenia in adults (1). In choosing among treatments, prescribers should consider the ability of FANAPT to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate FANAPT slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration. | 2013/9/10 |
| 5 | アメリカ | BESIFLOXACIN HYDROCHLORIDE | BAUSCH AND LOMB | 2009/5/28 | Besivancee™(besifloxacin ophthalmic suspension)0.6%, is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella lacunata*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections. (1) |
2013/9/10 |
| 6 | アメリカ | DRONEDARONE HYDROCHLORIDE | SANOFI AVENTIS US | 2009/7/1 | MULTAQ is an antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted (1,14). | 2013/9/10 |
| 7 | アメリカ | PRASUGREL HYDROCHLORIDE | ELI LILLY AND CO | 2009/7/10 | Effient is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows: •Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) (1.1) •Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1). |
2013/9/10 |
| 8 | アメリカ | ASENAPINE MALEATE | ORGANON SUB MERCK | 2009/8/13 | SAPHRIS is an atypical antipsychotic indicated for: •Acute treatment of schizophrenia in adults (1.1) •Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults (1.2) |
2013/9/10 |
| 9 | アメリカ | VIGABATRIN | LUNDBECK LLC | 2009/8/21 | SABRIL is an antiepileptic drug (AED) indicated for: • Refractory Complex Partial Seizures in Adults (1.1). It should be used as adjunctive therapy in patients who have responded inadequately to several alternative treatments. |
2013/9/10 |
| 10 | アメリカ | VIGABATRIN*III) | LUNDBECK LLC | 2009/8/21 | SABRIL is an antiepileptic drug (AED) indicated for: ・ Infantile Spasms (IS) - 1 Month to 2 Years of Age (1.1) |
2013/9/10 |
| 11 | アメリカ | TELAVANCIN HYDROCHLORIDE | THERAVANCE INC | 2009/9/11 | VIBATIV is a lipoglycopeptide antibacterial indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria. (1.1) | 2013/9/10 |
| 12 | アメリカ | PRALATREXATE | ALLOS | 2009/9/24 | FOLOTYN is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. (1) | 2013/9/10 |
| 13 | アメリカ | ROMIDEPSIN | CELGENE | 2009/11/5 | ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for: • Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy (1). |
2013/9/10 |
| 14 | アメリカ | ECALLANTIDE | DYAX CORP. | 2009/11/27 | KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. (1) | 2013/9/10 |
| 15 | アメリカ | DALFAMPRIDINE | ACORDA | 2010/1/22 | AMPYRA™ (dalfampridine) is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed (1, 14). | 2013/9/10 |
| 16 | アメリカ | COLLAGENASE CLOSTRIDIUM HISTOLYTICUM | AUXILIUM PHARMS | 2010/2/2 | XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. (1) | 2013/9/10 |
| 17 | アメリカ | VELAGLUCERASE ALFA | SHIRE HUMAN GENETIC | 2010/2/26 | VPRIV (velaglucerase alfa for injection) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease (1). | 2013/9/10 |
| 18 | アメリカ | CARGLUMIC ACID | ORPHAN EUROPE | 2010/3/18 | Carbaglu (carglumic acid) is a Carbamoyl Phosphate Synthetase 1 (CPS 1) activator indicated as: •Adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). (1.1) •Maintenance therapy for the treatment of chronic hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). (1.2) |
2013/9/10 |
| 19 | アメリカ | DIENOGEST/ ESTRADIOL VALERATE | BAYER HLTHCARE | 2010/5/6 | •Natazia is an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1) •The efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been evaluated. (1, 8.8) |
2013/9/10 |
| 20 | アメリカ | CABAZITAXEL | SANOFI AVENTIS US | 2010/6/17 | JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. (1) | 2013/9/10 |
| 21 | アメリカ | ALCAFTADINE | ALLERGAN | 2010/7/28 | LASTACAFT™ is a H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis (1) | 2013/9/10 |
| 22 | アメリカ | incobotulinumtoxinA*II) | MERZ PHARMS | 2010/7/30 | XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of: •Adults with cervical dystonia, to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients (1.1). •Blepharospasm in adults previously treated with onabotulinumtoxinA (Botox®) (1.2). |
2013/9/10 |
| 23 | アメリカ | ULIPRISTAL ACETATE | LAB HRA PHARMA | 2010/8/13 | ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive. (1) | 2013/9/10 |
| 24 | アメリカ | PEGLOTICASE | SAVIENT PHARMS | 2010/9/14 | KRYSTEXXA™ (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. (1) Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. (1) |
2013/9/10 |
| 25 | アメリカ | LURASIDONE HYDROCHLORIDE | SUNOVION PHARMS INC | 2010/10/28 | LATUDA is an atypical antipsychotic agent indicated for the treatment of patients with schizophrenia (1). Efficacy was established in four 6-week controlled studies of adult patients with sc hizophrenia (14.1). | 2013/9/10 |
| 26 | アメリカ | CEFTAROLINE FOSAMIL | CEREXA | 2010/10/29 | Teflaro™ is a cephalosporin antibacterial indicated for the treatment of the following infections caused by designated susceptible bacteria: •Acute bacterial skin and skin structure infections (ABSSSI) (1.1) •Community-acquired bacterial pneumonia (CABP) (1.2) |
2013/9/10 |
| 27 | アメリカ | TESAMORELIN ACETATE | EMD SERONO | 2010/11/10 | EGRIFTA™ is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. (1) Limitations of use (1): •Long-term cardiovascular benefit and safety of EGRIFTA™ have not been studied. •Not indicated for weight loss management (weight neutral effect). •There are no data to support improved compliance with antiretroviral therapies in HIV-positive patients taking EGRIFTA™. |
2013/9/10 |
| 28 | アメリカ | SPINOSAD | PARAPRO LLC | 2011/1/18 | NATROBA Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.(1) | 2013/9/10 |
| 29 | アメリカ | VILAZODONE HYDROCHLORIDE | FOREST LABS INC | 2011/1/21 | VIIBRYD is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, placebo-controlled trials in adult patients with MDD (1, 14). | 2013/9/10 |
| 30 | アメリカ | AZILSARTAN KAMEDOXOMIL*II) | TAKEDA PHARMS USA | 2011/2/25 | Edarbi is an angiotensin II receptor blocker indicated for the treatment of ypertension, either alone or in combination with other antihypertensive agents. (1) | 2013/9/10 |
| 31 | アメリカ | ROFLUMILAST | FOREST RES INST INC | 2011/2/28 | DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. (1, 14) Limitations of Use: DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm. (1, 14) |
2013/9/10 |
| 32 | アメリカ | BELIMUMAB | HUMAN GENOME SCIENCES INC. | 2011/3/9 | BENLYSTA is a B-Iymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. (1, 14) Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus (1). BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide (1). Use of BENLYSTA is not recommended in these situations. |
2013/9/10 |
| 33 | アメリカ | GADOBUTROL | BAYER HLTHCARE | 2011/3/14 | Gadavist is a gadolinium-based contrast agent indicated for intravenous use in diagnostic MRI in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system. (1) | 2013/9/10 |
| 34 | アメリカ | IPILIMUMAB | BRISTOL MYERS SQUIBB | 2011/3/25 | YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.(1) | 2013/9/10 |
| 35 | アメリカ | VANDETANIB | IPR PHARMS INC | 2011/4/6 | Vandetanib is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment related risks of vandetanib. |
2013/9/10 |
| 36 | アメリカ | ABIRATERONE ACETATE | JANSSEN BIOTECH | 2011/4/28 | ZYTIGA is a CYP17 inhibitor indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.(1) | 2013/9/10 |
| 37 | アメリカ | BOCEPREVIR | MERCK SHARP DOHME | 2011/5/13 | VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (≥18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. (1) VICTRELIS must not be used as a monotherapy. (1) |
2013/9/10 |
| 38 | アメリカ | FIDAXOMICIN | OPTIMER PHARMS | 2011/5/27 | DIFICID is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea (1.1). | 2013/9/10 |
| 39 | アメリカ | EZOGABINE | GLAXOSMITHKLINE | 2011/6/10 | POTIGA is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older. (1) | 2013/9/10 |
| 40 | アメリカ | BELATACEPT | BRISTOL MYERS SQUIBB | 2011/6/15 | •NULOJIX is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) •Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. (1.1) Limitations of Use: •Use only in patients who are EBV seropositive. (1.2,4,5.1) •Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. (1.2, 5,6) |
2013/9/10 |
| 41 | アメリカ | TICAGRELOR | ASTRAZENECA LP | 2011/7/20 | BRILINTA is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis. (1) BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily. (1, 5.2, 14). |
2013/9/10 |
| 42 | アメリカ | VEMURAFENIB | HOFFMANN LA ROCHE | 2011/8/17 | ZELBORAF™ is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test. (1, 5.10) Limitation of Use: ZELBORAF is not recommended for use in patients with wild-type BRAF melanoma. (5.10, 14) |
2013/9/10 |
| 43 | アメリカ | BRENTUXIMAB VEDOTIN | SEATTLE GENETICS | 2011/8/19 | ADCETRIS is a CD30-directed antibody-drug conjugate indicated for: •The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates (1.1). •The treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen (1.2). These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with ADCETRIS. |
2013/9/10 |
| 44 | アメリカ | ICATIBANT ACETATE | SHIRE ORPHAN THERAP | 2011/8/25 | FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (1) | 2013/9/10 |
| 45 | アメリカ | DEFERIPRONE | APOPHARMA INC | 2011/10/14 | FERRIPROX® (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. (1) Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival.(1) Limitation of Use •Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias. (1) |
2013/9/10 |
| 46 | アメリカ | RUXOLITINIB PHOSPHATE | INCYTE CORP | 2011/11/16 | Jakafi is a kinase inhibitor indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. (1) | 2013/9/10 |
| 47 | アメリカ | asparaginase Erwinia chrysanthemi | EUSA PHARMA USA | 2011/11/18 | ERWINAZE (asparaginase Erwinia chrysanthemi) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. (1) | 2013/9/10 |
| 48 | アメリカ | GLUCARPIDASE | BTG INTERNATIONAL INC | 2012/1/17 | ·VORAXAZE® (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. (1.1) ·Limitation of use: VORAXAZE is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate. (1.2) |
2013/9/10 |
| 49 | アメリカ | INGENOL MEBUTATE | LEO PHARMA AS | 2012/1/23 | Picato® gel is an inducer of cell death indicated for the topical treatment of actinic keratosis.(1) | 2013/9/10 |
| 50 | アメリカ | VISMODEGIB | GENENTECH | 2012/1/30 | ERIVEDGE™ (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.(1) | 2013/9/10 |
| 51 | アメリカ | IVACAFTOR | VERTEX PHARMS | 2012/1/31 | KALYDECO is classified as a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator. KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the G551D mutation. Limitations of Use: • Not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene. (1, 14) • KALYDECO has not been studied in other populations of patients with CF. (1, 14) |
2013/9/10 |
| 52 | アメリカ | LUCINACTANT | DISCOVERY LABS | 2012/3/6 | SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. (1) | 2013/9/10 |
| 53 | アメリカ | PEGINESATIDE ACETATE*Ⅴ) | TAKEDA PHARMS USA | 2012/3/27 | OMONTYS is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis (1.1). Limitations of Use OMONTYS is not indicated and is not recommended for use: · In patients with CKD not on dialysis (1.2). · In patients receiving treatment for cancer and whose anemia is not due to CKD (1.2). · As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.2). · OMONTYS has not been shown to improve symptoms, physical functioning or health-related quality of life (1.2). |
2013/9/10 |
| 54 | アメリカ | FLORBETAPIR F-18 | AVID RADIOPHARMS INC | 2012/4/6 | Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations (1). Limitations of Use •A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder (1). •Safety and effectiveness of Amyvid have not been established for: •Predicting development of dementia or other neurologic condition; •Monitoring responses to therapies (1). |
2013/9/10 |
| 55 | アメリカ | AVANAFIL | VIVUS | 2012/4/27 | STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (1) | 2013/9/10 |
| 56 | アメリカ | TALIGLUCERASE ALFA | PFIZER | 2012/5/1 | ELELYSO™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease. (1) | 2013/9/10 |
| 57 | アメリカ | LORCASERIN HYDROCHLORIDE | EISAI INC | 2012/6/27 | BELVIQ is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: •30 kg/m2 or greater (obese) (1) or •27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, (e.g., hypertension, dyslipidemia, type 2 diabetes) (1) Limitations of Use: •The safety and efficacy of coadministration with other products for weight loss have not been established (1) •The effect of BELVIQ on cardiovascular morbidity and mortality has not been established (1) |
2013/9/10 |
| 58 | アメリカ | CITRIC ACID/ MAGNESIUM OXIDE/ SODIUM PICOSULFATE | FERRING PHARMS AS | 2012/7/16 | PREPOPIK is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid which form magnesium citrate, an osmotic laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults (1) | 2013/9/10 |
| 59 | アメリカ | CARFILZOMIB | ONYX PHARMS | 2012/7/20 | KYPROLIS is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. (1,14) | 2013/9/10 |
| 60 | アメリカ | ACLIDINIUM BROMIDE | FOREST LABS INC | 2012/7/23 | TUDORZA PRESSAIR is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema(1) | 2013/9/10 |
| 61 | アメリカ | ZIV-AFLIBERCEPT*Ⅱ) | SANOFI AVENTIS US | 2012/8/3 | ZALTRAP, in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. (1) | 2013/9/10 |
| 62 | アメリカ | TBO-FILGRASTIM*Ⅱ) | SICOR BIOTECH | 2012/8/29 | Tbo-filgrastim is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1) | 2013/9/10 |
| 63 | アメリカ | LINACLOTIDE | FOREST LABS INC | 2012/8/30 | LINZESS is a guanylate cyclase-C agonist indicated in adults for treatment of: •Irritable bowel syndrome with constipation (IBS-C) (1.1) •Chronic idiopathic constipation (CIC) (1.2) |
2013/9/10 |
| 64 | アメリカ | ENZALUTAMIDE | ASTELLAS | 2012/8/31 | XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. (1) | 2013/9/10 |
| 65 | アメリカ | BOSUTINIB MONOHYDRATE | WYETH PHARMS INC | 2012/9/4 | • BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. (1) | 2013/9/10 |
| 66 | アメリカ | CHOLINE C 11 | MCPRF | 2012/9/12 | Choline C 11 Injection is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration. Limitation of Use: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer (1). |
2013/9/10 |
| 67 | アメリカ | TERIFLUNOMIDE | SANOFI AVENTIS US | 2012/9/12 | AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis (1) | 2013/9/10 |
| 68 | アメリカ | OCRIPLASMIN | THROMBOGENICS, INC | 2012/10/17 | JETREA is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion. (1) | 2013/9/10 |
| 69 | アメリカ | PERAMPANEL | EISAI INC | 2012/10/22 | FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older (1) | 2013/9/10 |
| 70 | アメリカ | OMACETAXINE MEPESUCCINATE | IVAX INTL | 2012/10/26 | SYNRIBO for Injection is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO. (1) | 2013/9/10 |
| 71 | アメリカ | CABOZANTINIB S-MALATE | EXELIXIS | 2012/11/29 | COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer(MTC). (1) | 2013/9/10 |
| 72 | アメリカ | RAXIBACUMAB | HUMAN GENOME SCIENCES INC. | 2012/12/14 | Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. (1) Limitations of Use: · The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. (1.2, 14.1) · There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. (1.2, 8.4) · Raxibacumab does not cross the blood-brain barrier and does not prevent or treat meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs. (1.2) |
2013/9/10 |
| 73 | アメリカ | PASIREOTIDE DIASPARTATE | NOVARTIS | 2012/12/14 | SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative (1) | 2013/9/10 |
| 74 | アメリカ | PONATINIB HYDROCHLORIDE | ARIAD | 2012/12/14 | Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy (1). This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig. | 2013/9/10 |
| 75 | アメリカ | LOMITAPIDE MESYLATE | AEGERION | 2012/12/21 | JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-highdensity lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH) (1). Limitations of Use •The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH (1). •The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined (1). |
2013/9/10 |
| 76 | アメリカ | TEDUGLUTIDE RECOMBINANT | NPS PHARMS INC | 2012/12/21 | GATTEX® (teduglutide [rDNA origin]) for injection is a glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. (1). | 2013/9/10 |
| 77 | アメリカ | BEDAQUILINE FUMARATE | JANSSEN THERAP | 2012/12/28 | SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. SIRTURO is not indicated for the treatment of latent, extra-pulmonary or drug-sensitive tuberculosis. (1) | 2013/9/10 |
| 78 | アメリカ | CROFELEMER | SALIX PHARMS | 2012/12/31 | FULYZAQ is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy (1) | 2013/9/10 |
| 79 | アメリカ | ALOGLIPTIN BENZOATE/ METFORMIN HYDROCHLORIDE | TAKEDA PHARMS USA | 2013/1/25 | KAZANO is a dipeptidyl-peptidase-4 (DPP-4) inhibitor and a biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1.1) Important Limitation of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2) |
2013/9/10 |
| 80 | アメリカ | MIPOMERSEN SODIUM | GENZYME CORP | 2013/1/29 | KYNAMRO™ is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-choleste rol (LDL-C), apolipoprotein B (apoB), total cholesterol (TC), and non-high density lipoprotein-cholesterol (nonHDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)(1). Limitations of Use: ·The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH. ·The effect of KYNAMRO on cardiova scular morbidity and mortality has not been determined. ·The use of KYNAMRO as an adjunct to LDL apheresis is not recommended. |
2013/9/10 |
| 81 | アメリカ | POMALIDOMIDE | CELGENE | 2013/2/8 | POMALYST is a thalidomide analogue indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. | 2013/9/10 |
| 82 | アメリカ | ADO-TRASTUZUMAB EMTANSINE*II) | GENENTECH | 2013/2/22 | KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: ·Received prior therapy for metastatic disease, or ·Developed disease recurrence during or within six months of completing adjuvant therapy. (1) |
2013/9/10 |
| 83 | アメリカ | OSPEMIFENE | SHIONOGI INC | 2013/2/26 | OSPHENA is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy,due to menopause (1) | 2013/9/10 |
| 84 | アメリカ | TECHNETIUM TC 99M TILMANOCEPT | NAVIDEA BIOPHARMS | 2013/3/13 | Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated for lymphatic mapping with a hand-held gammacounter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma. (1) | 2013/9/10 |
| 85 | アメリカ | DIMETHYL FUMARATE | BIOGEN IDEC INC | 2013/3/27 | TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis (1) | 2013/9/10 |
| 86 | アメリカ | CANAGLIFLOZIN | JANSSEN PHARMS | 2013/3/29 | INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) Limitation of Use: • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1) |
2013/9/10 |
| 87 | アメリカ | RADIUM RA-223 DICHLORIDE | BAYER HLTHCARE | 2013/5/15 | Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. (1) | 2013/9/10 |
| 88 | アメリカ | TRAMETINIB DIMETHYL SULFOXIDE | GLAXOSMITHKLINE LLC | 2013/5/29 | MEKINIST is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. (1) Limitation of use: MEKINIST is not indicated for the treatment of patients who have received prior BRAF inhibitor therapy. (1) |
2013/9/10 |
| 89 | アメリカ | DABRAFENIB MESYLATE | GLAXOSMITHKLINE | 2013/5/29 | TAFINLAR is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. (1, 2.1) Limitation of use: TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma. (1, 5.2) |
2013/9/10 |
| 90 | アメリカ | AFATINIB DIMALEATE | BOEHRINGER INGELHEIM | 2013/7/12 | GILOTRIF is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test (1) Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations (1) |
2013/9/10 |
FDA＿HPにあるSearch Drug Approvals by Month Using Drugs@FDAよりNDA Chemical Typesが１（New molecular entity (NME) ）およびBLAとして承認されたもののうち、日本で2013年9月26日時点で未承認のものを掲載した。（引き続き調査中）
注１）企業名は調査時、効能・効果は承認時の情報に基づき記載している。
注２）マーカーは米国および欧州の未承認薬一覧のうち、米国と欧州で有効成分名が同じ医薬品。
*I）販売名がULESFIAに変更されている。
*II）類似医薬品が日本で承認されている。
*III）No.9と同じ成分であるが別申請として扱われている。
*IV）現在販売されていない。
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