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米国新医薬品承認情報検索ネット 更新日:2016/10/12

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(BLA # 761042) ERELZI ETANERCEPT-SZZS SANDOZ INC 2016-08-30 Rheumatoid Arthritis,? Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis Injection, single-dose prefilled syringe with BD UltraSafe Passive? Needle Guard (3) Biologics, humanized monoclonal antibody Label Information
(NDA # 207963) PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE New formulation or new manufacturer EXELA PHARMA SCS LLC 2016-08-22 Nausea, vomiting Injection, single dose vial Label Information
(NDA # 207621) TROXYCA ER OXYCODONE HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE PFIZER INC 2016-08-19 Pain Extended release capsule Label Information
(NDA # 022445) SUSTOL GRANISETRON New formulation or new manufacturer HERON THERAPEUTICS 2016-08-09 Nausea, vomiting Injection, Extended release injection Label Information
(NDA # 208401) QBRELIS LISINOPRIL New dosage form SILVERGATE PHARMS 2016-07-29 Hypertension, heart failure , Myocardial Infarction Oral Solution Label Information
(NDA # 208471) ADLYXIN LIXISENATIDE New molecular entity (NME) Standard review drug SANOFI-AVENTIS US 2016-07-27 Type II diabetes mellitus Injection, prefilled pen Label Information
(NDA # 208624) VIEKIRA XR DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR New dosage form ABBVIE INC 2016-07-22 HCV Extended-release tablets Label Information
(NDA # 208271) RELISTOR METHYLNALTREXONE BROMIDE New dosage form SALIX PHARMS INC 2016-07-19 Opioid-induced constipation Injection single-dose pre-filled syring, tablet Label Information
(NDA # 203324) PHOTREXA RIBOFLAVIN 5'-PHOSPHATE SODIUM New dosage form Priority review drug AVEDRO INC 2016-07-15 Photoenhancer Injection, glass syringe Label Information
(NDA # 203324) PHOTREXA VISCOUS IN DEXTRAN 20% RIBOFLAVIN 5'-PHOSPHATE SODIUM New dosage form Priority review drug AVEDRO INC 2016-07-15 Photoenhancer Injection, glass syringe Label Information
(NDA # 208524) BELVIQ XR LORCASERIN HYDROCHLORIDE New formulation or new manufacturer EISAI INC 2016-07-15 Chronic weight management Tablet Label Information
(NDA # 207648) SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL New combination Standard review drug FRESENIUS KABI USA 2016-07-13 Parenteral nutrition Lipid emulsion, injection Label Information
(NDA # 208073) XIIDRA LIFITEGRAST New molecular entity (NME) Priority review drug SHIRE DEV LLC 2016-07-11 Dry eye Eye drop Label Information
(NDA # 205525) SYNDROS DRONABINOL New dosage form INSYS DEV CO INC 2016-07-01 Anorexia, nausea and vomiting Oral Solution Label Information
(NDA # 208032) KOVANAZE OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE New combination Standard review drug ST RENATUS 2016-06-29 Regional anesthesia Nasal spray in pre-filled, single-use sprayer Label Information
(NDA # 208341) EPCLUSA SOFOSBUVIR; VELPATASVIR New molecular entity (NME) Priority review drug GILEAD SCIENCES INC 2016-06-28 HCV Tablet Label Information
(NDA # 208010) RAYALDEE CALCIFEDIOL New formulation or new manufacturer Standard review drug OPKO IRELAND GLOBAL 2016-06-17 Hyperparathyroidism Extended release capsule Label Information
(NDA # 208424) GONITRO NITROGLYCERIN New dosage form Standard review drug POHL BOSKAMP 2016-06-08 Attack Subligual powder Label Information
(NDA # 208025) LANSOPRAZOLE LANSOPRAZOLE New formulation or new manufacturer Standard review drug DEXCEL PHARMA 2016-06-07 Heartburn Delayed release tablet, orally disintegrating tablets Label Information
(NDA # 206302) BYVALSON NEBIVOLOL HYDROCHLORIDE; VALSARTAN New combination Standard review drug FOREST LABS LLC 2016-06-03 hypertension Tablet Label Information
(NDA # 208547) NETSPOT GALLIUM GA 68 DOTATATE New molecular entity (NME) Priority review drug ADVANCED ACCELERATOR APPLICATIONS USA INC 2016-06-01 Radioactive diagnostic agent indicate Injection, kit Label Information
(NDA # 207999) OCALIVA OBETICHOLIC ACID New molecular entity (NME) INTERCEPT PHARMACEUTICALS INC 2016-05-27 primary biliary c h o l a n g i t i s (PBC) Tablets Label Information
(NDA # 208026) JENTADUETO XR LINAGLIPTIN;METFORMIN HYDROCHLORIDE New combination Standard review drug BOEHRINGER INGELHEIM 2016-05-27 Type 2 diabetes mellitus extended-release tablet Label Information
(NDA # 208054) AXUMIN FLUCICLOVINE (18F) New molecular entity (NME) BLUE EARTH DIAGNOSTICS LTD 2016-05-27 Positron emission tomography (PET) imaging injection, sollution Label Information
(BLA # 761029) ZINBRYTA DACLIZUMAB New molecular entity (NME) BIOGEN 2016-05-27 Multiple sclerosis (MS) Injection: 150 mg/mL solution in a single-dose prefilled syringe Biologics, humanized monoclonal antibody Label Information
(NDA # 204442) PROBUPHINE BUPRENORPHINE HYDROCHLORIDE New dosage form Priority review drug TITAN PHARMS 2016-05-26 opioid dependence implant is an ethylene vinyl acetate (EVA) implant Label Information
(BLA # 761034) TECENTRIQ ATEZOLIZUMAB GENENTECH INC 2016-05-18 Urothelial carcinoma injection, sollution Biologics, monoclonal antibody Label Information
(NDA # 208081) AMELUZ AMINOLEVULINIC ACID HYDROCHLORIDE New dosage form Standard review drug BIOFRONTERA PHARMA AG 2016-05-10 Actinic keratoses of mild-to-moderate severity on the face and scalp Gel Label Information
(NDA # 207318) NUPLAZID PIMAVANSERIN TARTRATE New molecular entity (NME) Priority review drug ACADIA PHARMS INC 2016-04-29 hallucinations and delusions associated with Parkinsonfs disease, psychosis. Tablet Label Information
(NDA # 208216) AZACITIDINE AZACITIDINE New formulation or new manufacturer Standard review drug ACTAVIS LLC 2016-04-29 FAB myelodysplastic syndrome (MDS Injection,lyophilized powder Label Information
(NDA # 208251) OTOVEL CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE New formulation or new manufacturer Standard review drug LABORATORIOS SALVAT 2016-04-29 Infection Otic solution Label Information
(NDA # 208277) FYCOMPA PERAMPANEL New dosage form Standard review drug EISAI INC 2016-04-29 Epilepsy Tablets, oral suspension Label Information
(NDA # 208289) AKOVAZ EPHEDRINE SULFATE Drug already marketed without an approved NDA Standard review drug FLAMEL IRELAND LTD 2016-04-29 hypotension Injection Label Information
(NDA # 208090) XTAMPZA ER OXYCODONE New formulation or new manufacturer Standard review drug COLLEGIUM PHARM INC 2016-04-26 Pain Extended-release capsules Label Information
(NDA # 208253) ACTICLATE CAP DOXYCYCLINE HYCLATE New formulation or new manufacturer Standard review drug AQUA PHARMS 2016-04-26 Infection Capsule Label Information
(NDA # 208294) BEVESPI AEROSPHERE FORMOTEROL FUMARATE; GLYCOPYRROLATE New combination Standard review drug PEARL THERAPS INC 2016-04-25 Chronic obstructive pulmonary disease (COPD). Inhalation aerosol Label Information
(NDA # 208551) TRIFERIC FERRIC PYROPHOSPHATE CITRATE New dosage form Standard review drug ROCKWELL MEDICAL INC 2016-04-25 Chronic kidney disease (HDD-CKD) Solution Label Information
(NDA # 208692) CABOMETYX CABOZANTINIB S-MALATE New dosage form Priority review drug EXELIXIS INC 2016-04-25 Advanced renal cell carcinoma (RCC) tablets Label Information
(NDA # 206356) ORFADIN NITISINONE New dosage form Standard review drug SOBI 2016-04-22 Hereditary tyrosinemia type 1 (HT-1) Oral suspension Label Information
(NDA # 206679) SIMVASTATIN SIMVASTATIN New dosage form Standard review drug ROSEMONT PHARMS LTD 2016-04-21 Primary hyperlipidemia , dyslipidemia Oral suspension: Label Information
(NDA # 203324) PHOTREXA RIBOFLAVIN 5'-PHOSPHATE SODIUM New dosage form Priority review drug AVEDRO INC 2016-04-15 Topical anesthesia Topical ophthalmic solution Label Information
(NDA # 203324) PHOTREXA VISCOUS IN DEXTROSE 20% RIBOFLAVIN 5'-PHOSPHATE SODIUM New dosage form Priority review drug AVEDRO INC 2016-04-15
(NDA # 206911) BROMSITE BROMFENAC SODIUM New formulation or new manufacturer Standard review drug INSITE VISION INC 2016-04-11 Inflammation, ocular pain Topical ophthalmic solution Label Information
(NDA # 208573) VENCLEXTA VENETOCLAX New molecular entity (NME) Priority review drug, orphan drug ABBVIE INC 2016-04-11 Chronic lymphocytic leukemia (CLL Tablet Label Information
(NDA # 204630) PROVAYBLUE METHYLENE BLUE New formulation or new manufacturer Standard review drug PROVEPHARM SAS 2016-04-08 Acquired methemoglobinemia Injection, single-dose ampule Label Information
(NDA # 205703) ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE New formulation or new manufacturer Standard review drug HQ SPCLT PHARMA 2016-04-07 Tachycardia, hypertension Injection, premixed Injection bag Label Information
(NDA # 205703) ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE New formulation or new manufacturer Standard review drug HQ SPCLT PHARMA 2016-04-07
(BLA # 125544) INFLECTRA INFLIXIMAB-DYYB Biosimilar CELLTRION INC 2016-04-05 Crohnfs Disease, pediatric Crohnfs disease, ulcerative colitis , rheumatoid arthritis, ankylosing spondylitis,psoriatic arthritis, plaque psoriasis Injection: lyophilized dry powder Biologics, chimeric human-murine monoclonal antibody Label Information
(NDA # 208215) DESCOVY EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE New combination Standard review drug GILEAD SCIENCES INC 2016-04-04 HIV-1 infection Tablet Label Information
(NDA # 208114) DEFITELIO GENTIUM SPA 2016-03-30 Hepatic veno-occlusive disease (VOD) Injection, solution Label Information
(BLA # 761033) CINQAIR RESLIZUMAB TEVA RESPIRATORY LLC 2016-03-23 Asthma Injection, solution Biologics, injection, monoclonal antibody Label Information
(BLA # 125521) TALTZ IXEKIZUMAB ELI LILLY AND CO 2016-03-22 Plaque psoriasis Injection, a single-dose prefilled autoinjector Biologics, injection, humanized interleukin-17A antagonist Label Information
(BLA # 125509) ANTHIM OBILTOXAXIMAB ELUSYS THERAPEUTICS INC 2016-03-18 Inhalational anthrax due to B. anthracis Injection, solution in single-dose vial. Biologics, monoclonal antibody Label Information
(NDA # 022165) CAMBIA DICLOFENAC POTASSIUM New dosage form Standard review drug DEPOMED INC 2016-03-10 Migraine attacks Oral solution Label Information
(NDA # 207155) EVOMELA MELPHALAN HYDROCHLORIDE New formulation or new manufacturer Standard review drug SPECTRUM PHARMS 2016-03-10 Multiple myeloma Injection, lyophilized powder Label Information
(NDA # 203050) PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE New formulation or new manufacturer Standard review drug DR REDDYS LABS LTD 2016-03-01 Delayed nausea , vomiting Injection, single-dose vial Label Information
(NDA # 208351) ODEFSEY EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE New combination Priority review drug GILEAD SCIENCES INC 2016-03-01 HIV-1 infection Tablet Label Information
(NDA # 208135) TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE Drug already marketed without an approved NDA Standard review drug ALCON RES LTD 2016-02-29 Topical ophthalmic anesthetic Sterile ophthalmic solution Label Information
(NDA # 207154) ACZONE DAPSONE New formulation or new manufacturer Standard review drug ALLERGAN 2016-02-24 Acne vulgaris Gel Label Information
(NDA # 208246) XELJANZ TOFACITINIB New dosage form Standard review drug PFIZER INC 2016-02-23 Active rheumatoid arthritis Tablet Label Information
(NDA # 205836) BRIVIACT BRIVARACETAM New molecular entity (NME) Standard review drug UCB INC 2016-02-18 Partial-onset seizures Tablet, oral solution, injection Label Information
(NDA # 202172) ROSUVASTATIN ZINC ROSUVASTATIN ZINC New active ingredient Standard review drug WATSON LABS INC 2016-02-12 Hypertriglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia (HoFH) Tablet Label Information
(NDA # 208079) SERNIVO BETAMETHASONE DIPROPIONATE New dosage form Standard review drug PROMIUS PHARMA LLC 2016-02-05 Plaque psoriasis Spray Label Information
(NDA # 207174) PARICALCITOL PARICALCITOL New formulation or new manufacturer Standard review drug ACCORD HLTHCARE 2016-02-04 Hyperparathyroidism Injection is available as a single-dose vial Label Information
(NDA # 207916) CETYLEV ACETYLCYSTEINE New dosage form Standard review drug ARBOR PHARMS LLC 2016-01-29 Hepatic injury Effervescent tablets Label Information
(NDA # 204326) ADZENYS XR-ODT AMPHETAMINE New formulation or new manufacturer Standard review drug NEOS THERAPS 2016-01-28 Attention Deficit Hyperactivity Disorder (ADHD) Extended-release orally disintegrating tablets Label Information
(NDA # 208223) ZEMBRACE SYMTOUCH SUMATRIPTAN SUCCINATE New formulation or new manufacturer Standard review drug DR REDDYS LABS LTD 2016-01-28 Migraine Injection, 3-mg prefilled, ready-to use, single-dose disposable autoinjector. (3). Label Information
(NDA # 208261) ZEPATIER ELBASVIR; GRAZOPREVIR New combination Priority review drug MERCK SHARP DOHME 2016-01-28 HCV Tablet a fixed-dose combination Label Information
(NDA # 206099) ONZETRA XSAIL SUMATRIPTAN SUCCINATE New dosage form Standard review drug AVANIR PHARMS 2016-01-27 Acute treatment of migraine Capsule in disposable nosepiece, breath-powered delivery device o Label Information
(NDA # 208056) DEXILANT SOLUTAB DEXLANSOPRAZOLE New dosage form Standard review drug TAKEDA PHARMS USA 2016-01-26 Healing, healing Delayed-release capsules, Delayed-release orally disintegrating tablets Label Information
(NDA # 208143) READI-CAT 2 BARIUM SULFATE Drug already marketed without an approved NDA Standard review drug BRACCO 2016-01-15 Radiographic contrast agents Oral suspension Label Information
(NDA # 208036) E-Z-HD BARIUM SULFATE Drug already marketed without an approved NDA Standard review drug BRACCO 2016-01-11 Radiographic contrast agent Oral suspension, a single-dose bottle for reconstitution Label Information
(NDA # 204016) ZOLEDRONIC ACID ZOLEDRONIC ACID New formulation or new manufacturer Standard review drug HOSPIRA INC 2015-12-28 Hypercalcemia of malignancy, multiple myeloma, bone metastases Injection, single-dose premixed bag Label Information
(NDA # 205934) DOCETAXEL DOCETAXEL New formulation or new manufacturer Standard review drug TEIKOKU PHARMA USA 2015-12-22 Breast Cancer (BC), Non-Small Cell Lung Cancer (NSCLC), Hormone Refractory Prostate Cancer (HRPC), Gastric Adenocarcinoma (GC). Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): Injection , solution in a single- and multiple- dose vial (3) Label Information
(NDA # 207988) ZURAMPIC LESINURAD New molecular entity (NME) Standard review drug ARDEA BIOSCIENCES INC 2015-12-22 Hyperuricemia Tablet Label Information
(NDA # 207947) UPTRAVI SELEXIPAG New molecular entity (NME) ACTELION PHARMS LTD 2015-12-21 Pulmonary arterial hypertension (PAH, Tablet Label Information
(NDA # 207865) EMEND APREPITANT New dosage form Priority review drug MERCK SHARP DOHME 2015-12-17 Nausea and vomiting capsules: 40 mg; 80 mg; 125 mg (3) EMEND for oral suspension: 125 mg (3) Label Information
(NDA # 205692) BASAGLAR INSULIN GLARGINE New formulation or new manufacturer Standard review drug ELI LILLY AND CO 2015-12-16 With type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Injection, 100 units/mL (U-100) in 3 mL prefilled BASAGLAR? KwikPen? delivery device. (3) Label Information
(NDA # 022225) BRIDION SUGAMMADEX New molecular entity (NME) Priority review drug ORGANON USA INC 2015-12-15 Reversal of neuromuscular blockade Injection, single-dose vial for bolus injection Label Information
(NDA # 208159) VISTOGARD URIDINE TRIACETATE 10 ? Priority review drug WELLSTAT THERAP 2015-12-11 Emergency treatment of adult and pediatric patients:following a fluorouracil or capecitabine overdose Oral granule Label Information
(NDA # 208434) ALECENSA ALECTINIB New molecular entity (NME) Priority review drug HOFFMAN-LA ROCHE 2015-12-11 Metastatic non-small cell lung cancer (NSCLC) Capsule Label Information
(NDA # 207986) OTIPRIO CIPROFLOXACIN New formulation or new manufacturer Standard review drug OTONOMY INC. 2015-12-10 Infection Otic Suspension: Each OTIPRIO vial contains 1 mL of 6% (60 mg/mL) ciprofloxacin otic suspension Label Information
(BLA # 125561) KANUMA SEBELIPASE ALFA ALEXION PHARM 2015-12-08 Lysosomal Acid Lipase (LAL) deficiency Injection, 20 mg/10 mL (2 mg/mL) solution in single-use vials Biologics, hydrolytic lysosomal cholesteryl ester and triacylglycerol-specific enzyme Label Information
(NDA # 208194) BENDEKA BENDAMUSTINE HYDROCHLORIDE New formulation or new manufacturer Standard review drug EAGLE PHARMS 2015-12-07 Chronic lymphocytic leukemia (CLL), Indolent B-cell non-Hodgkin lymphoma (NHL) Injection: 100 mg/4 mL (25 mg/mL) in a multiple-dose vial (3). Label Information
(NDA # 207960) QUILLICHEW ER METHYLPHENIDATE HYDROCHLORIDE New dosage form Standard review drug PFIZER INC 2015-12-04 Attention Deficit Hyperactivity Disorder (ADHD). Extended release chewable tablet Label Information
(BLA # 761035) EMPLICITI ELOTUZUMAB Orphan drug BRISTOL MYERS SQUIBB 2015-11-30 Multiple myeloma Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution Biologics, immunostimulatory monoclonal antibody Label Information
(BLA # 125547) PORTRAZZA NECITUMUMAB Standard review drug. Orphan drug ELI LILLY CO 2015-11-24 Metastatic squamous non-small cell lung cancer. Injection, solution in a single-dose vial Biologics, monoclonal antibody Label Information
(NDA # 207920) NEXIUM 24HR ESOMEPRAZOLE MAGNESIUM New dosage form Standard review drug ASTRAZENECA LP 2015-11-23 Frequent heartburn Delayed release tablet Label Information
(NDA # 208462) NINLARO IXAZOMIB CITRATE New molecular entity (NME) Priority review drug, Orphan drug  MILLENNIUM PHARMS 2015-11-20 Multiple myeloma Combination , Capsule Label Information
(NDA # 208411) NARCAN NALOXONE HYDROCHLORIDE New dosage form Priority review drug ADAPT PHARMA 2015-11-18 known or suspected opioid overdose Nasal spray Label Information
(BLA # 761036) DARZALEX DARATUMUMAB New molecular entity (NME) Priority review drug, Orphan drug  JANSSEN BIOTECH 2015-11-16 multiple myeloma Injection, solution in a single-dose vial Label Information
(NDA # 208065) TAGRISSO OSIMERTINIB MESYLATE New molecular entity (NME) Priority review drug, Orphan drug  ASTRAZENECA PHARMS 2015-11-13 Non-small cell lung cancer (NSCLC) Tablet Label Information
(NDA # 206192) COTELLIC COBIMETINIB FUMARATE New molecular entity (NME) Priority review drug, Orphan drug  GENENTECH INC 2015-11-10 Unresectable or metastatic melanoma Tablet Label Information
(NDA # 208183) ULTRAVATE HALOBETASOL PROPIONATE New dosage form Standard review drug FERNDALE LABS INC 2015-11-06 plaque psoriasis Lotion
(NDA # 207561) GENVOYA COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE New molecular entity (NME) Standard review drug GILEAD SCIENCES INC 2015-11-05 HIV Combination , Tablets Label Information
(BLA # 125526) NUCALA MEPOLIZUMAB GLAXOSMITHKLINE LLC 2015-11-04 Severe asthma injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution. (3) Biologics, monoclonal antibody Label Information
(NDA # 207923) SEEBRI GLYCOPYRROLATE New dosage form Standard review drug NOVARTIS PHARMS CORP 2015-10-29 Chronic obstructive pulmonary disease (COPD) Inhalation powder Label Information
(NDA # 207930) UTIBRON GLYCOPYRROLATE ; INDACATEROL MALEATE New combination ? Standard review drug NOVARTIS PHARMS CORP 2015-10-29 Chronic obstructive pulmonary disease (COPD) Inhalation powder: UTIBRON capsules contain 27.5 mcg of indacaterol and 15.6 mcg glycopyrrolate inhalation powder for use with the NEOHALER device (3) Label Information
(NDA # 204767) ACETAMINOPHEN ACETAMINOPHEN New formulation or new manufacturer Standard review drug FRESENIUS KABI USA 2015-10-28 Management of mild to moderate pain, fever Label Information
(BLA # 125513) STRENSIQ ASFOTASE ALFA ALEXION PHARM 2015-10-23 Perinatal/infantile-and juvenile-onset hypophosphatasia (HPP) Injection, single-use vials, subcutaneous Label Information

 

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