2009 9 42 () 9 15 7 III 11 16 14 12 10 8 6 4 2 0 12 17 () 15 10 () 1
1 9 4 ( 6)Me-too ( 5) 1 ( 3) 4 ( 2) 4 3 50 100 ( 4) Xanodyne ProSorb-DCumberland CaldolorKing Embeda 3 20 50 1 2009 9 / () uliprisnil acetate Me-too Ella ellaone Myonova HRA Pharma () /diclofenac potassium / ProSorb- D/ Xanodyne 1,2 ( ) /ibuprofen / Caldolor Cumberla nd Pharmac euticals 1,2 ( ) /fluticasone, topical / SALVAT (/ ) + /morphine+ naltrexone / Embeda King Pharmac euticals 2
/ () Synflorix Streptorix Streptorix GlaxoSmi thkline () DNA valrubicin Valstar Valtaxin Endo Pharmac euticals DNA AYP ( ) /influenza vaccine Zilbrix Zilbrix Hib Solvay () /influenza vaccine, Panvax, CSL () 2 15 8 ( 2) ( 6) 1 ( Allos Therapeutics T Folotyn) me-too ( 5) 2 ( 3) 5 4( 50 100 ) 1 Novartis Valturna(+)Pierre Fabre Javlor() Senju Bepreve 3( 20 50 ) 12 ( 020 ) 3
4 2 2009 9 / () pralatrexate Folotyn Allos Therapeuti cs T- () /vinflunine ditartrate me-too Javlor Pierre Fabre () telavancin me-too Arbelic Theravanc e MRSA () guanfacine Connexy n Shire () /aztreona mlysine / Cayston Corus 1020 Gilead Sciences () bepotastine / Bepreve Senju ( ) + /aliskiren + valsartan / Valturna Novartis II ( ) /metoclopra mide,zydis / Wilmingt Metozolv ODT Salix 5- ( ) whole virion vaccine Panflu, Panflu.1 Sinovac Biotech () influenza vaccine, Arepanrix GlaxoSmit hkline () influenza vaccine, Sanofi-Ave ntis () influenza vaccine, Panvax, CSL ()
/ () influenza vaccine, Focetria Novartis () influenza vaccine, Fluvirin Novartis () influenza vaccine (egg-based), Monova AstraZene ca () MedIm 3 7 3 ( 6) 2 ( 3) 1 ( 2) 4 5(100 ) Pharming Rhucin 4( 50 100 ) 2 Merck & Co NicOx naproxcinod 11 5 ( 6) 4 me-too ( 5) 4 ( 4) 1 2 5 Mondobiotech aviptadil 50 100 ( 3) 8 5
3 2009 9 () Rhucin Pharming ( ) belatacept Bristol-My ers Squibb CD28 T ( ) Niemann-Pick + /atorvastatin + ezetimibe Merck Co & C1 HMGCoA ( ) naproxcinod NicOx ( ) /colistin sodium Forest Laboratori es () influenza vaccine, GlaxoSmit hkline () influenza vaccine, Novartis () /aviptadil Mondobiot ech (COPD ) NN-5401 Novo Nordisk 14 ( ) 6
() IGF-1 OSI-906 OSI Pharmace uticals r 6 () /lobeglitazon e Chong Kun Dang 2 ( ) me-too canagliflozin Mitsubishi Tanabe Pharma SGLT-2 2 ( ) me-too MDV-3100 Medivatio n ( ) me-too PLX-4032 Plexxikon B-raf () me-too NN-1250 Novo Nordisk 17 ( ) MET PF-2341066 Pfizer ALK () /fusidic acid Cempra () MEDI-8662 AstraZene ca () 7
1 73 24 ( 19 ) 36 ( 35 ) 13 ( 1 ) 19 9 () 4 2009 9 SFDA 8
36 (35 ) 5 2009 9 SFDA 9
13 (1 ) 6 2009 9 SFDA 2 135 ( 94 ) 7 2009 9 SFDA ( ) () ( /) Polyethylene Glycol Eye Drops Levofloxacin Eye Drops Systane Ultra Cravit Alcon Laboratories,Inc Santen Pharmaceutical Co.,Ltd.Noto Plant Lornoxicam Xafon Nycomed Austria GmbH 10
( ) () ( /) Meloxicam Mobic Boehringer Ingelheim Pharma GmbH & Co. KG Etoricoxib Arcoxia Merck & Co., Inc. Probenecid Melilotus Extract Tablet -M SETUS-M D.K.PHARMA CHEM PVT.LTD Seiko Eiyo Yakuhin Co.,LTD Glucosamine Sulfate Capsules Neurotropin Viartril-S Neurotropin Rottapharm Ltd. Nippon Zoki Pharmaceutical Co.,Ltd. Ipratropium Bromide Boehringer Ingelheim Pharma GmbH & Co. KG Loratadine and Pseudoephedrine Sulfate Sustained Release CLARINAS E Schering-Plough N.V. Labo Serrapeptase Enteric-coated Seradase Weidar Chem. & Pharm. Co., Ltd. Amisulpride Zuclopenthixol Acetate Escitalopram Oxalate Fluvoxamine Maleate SANOFI WINTHROP INDUSTRIE Clopixol-Acu H.Lundbeck A/S phase Lexapro H.Lundbeck A/S Solvay Pharmaceuticals Luvox S.A. Olopatadine Hydrochloride Yokkaichi Plant of Kyowa Hakko Kirin Co.,Ltd. Olopatadine Hydrochloride Allelock Kyowa Hakko Kirin Co.,Ltd. Fuji Plant 11
( ) () ( /) Desloratadine AERIUS Schering-Plough Labo.N.V. Fexofenadine Hydrochloride Raltiva Ranbaxy Limited Laboratories Pfizer Ireland Azithromycin Pharmaceuticals Erythromycin ANUH PHARMA Cyclic LIMITED 11,12-Carbonate Azithromycin for Pfizer Ireland Zithromax Pharmaceuticals Novartis Grimsby Telbivudine Limited Axellia Pharmaceuticals Gramicidin Ltd. Itraconazole NIFTY LABS PVT.LTD Orchid Chemicals & Cefixime Pharmaceuticals Ltd cefradine ACS Dobfar S.p.A. Cefmetazole FARMABIOS S.P.A Sodium Influenza vaccine(sub-unit) Agrippal Novartis Vaccines and Diagnostics S.R.L. Trivalent Inactivated Split virion Influenza Vaccine Fluviral ID BIOMEDICAL CORPORATION OF QUEBEC (Vero ) Rabies Vaccine Prepared on Vero Cell for Human Use VERORAB Lantigen B Bruschettini S.R.L Bicalutamide CORDEN PHARMA GMBH 12
( ) () ( /) Leuprorelin Acetate Microspheres for Takeda Pharmaceutical Company Limited, Hikari Plant Gefitinib Iressa AstraZeneca UK Limited Cytarabine for Cytosar Pfizer Italia s.r.l. Fludarabine Phosphate for Fludara Baxter Oncology GmbH Mitomycin Mitomycin for Hofu Plant of KYOWA HAKKO BIO CO.,LTD. Kyowa Hakko Kirin Co.,Ltd. Fuji Plant Bortezomib for Velcade Ben Venue Laboratories Inc. Sorafenib Bayer Schering Pharma Tosylate Nexavar AG Erlotinib F. Hoffmann - La Roche Hydrochloride Ltd. L-Asparaginase Kyowa Hakko Kirin Leunase for Co.,Ltd. Fuji Plant Docetaxel Aventis Pharma Dagenham Teniposide Bristol-Myers Squibb S. r. Vumon l Propofol Sochinaz SA Sevoflurane Ultane Tolterodine L-Tartrate Sustained Release Capsules Aesica Queenborough Limited Catalent Pharma Solutions Inc. Tolterodine Tartrate Detrusitol Pfizer Italia S.r.l 13
( ) () ( /) Finasteride Proscar Merck Sharp & Dohme Quimica de Puerto Rico Ltd. Vardenafil Hydrochloride Levitra Bayer Schering Pharma AG Alendronate D3 (II) Sodium Vitamin and D3 Frosst Iberica SA Somatostatin Polypeptide Laboratories, Inc. Sitagliptin Phosphate Pioglitazone Hydrochloride JANUVIA Actos Merck Sharp & Dohme Italia SPA Takeda Pharmaceutical Company Limited, Osaka Plant Insulin Glargine LANTUS Sanofi-Awentis Deutschland GmbH Protamine Recombinant Human Insulin N SciLin N BIOTON S.A. 30 Insulin Aspart 30 30 NovoMix 30 Penfill Novo Nordisk A/S Recombinant Human Insulin R SciLin R BIOTON S.A. / Tacrolimus Ointment Protopic Astellas Toyama Co., Ltd. Toyama Plant Triamcinolone Acetonide Laboratorio Italiano Biochimico Farmaceutico Lisapharma S.P.A. 14
( ) () ( /) Oxycodone Hydrochloride Prolonged-release BARD PHARMACEUTICALS LIMITED - Compound Gestodene levonorgestrel Intrauterine System Chlorquinaldol-P romestriene Vaginal Minulet Mirena Colposeptine Wyeth Medica Ireland Bayer Schering Pharma Oy Laboratoire Theramex Estradiol Gel Oestrogel Laboratoires BESINS INTERNATIONAL Estradiol and Drospirenone Angeliq Schering GmbH & Co. Produktions KG Diosmin ALVENOR LES LABORATOIRES SERVIER INDUSTRIE Ecabet Granules Sodium Mitsubishi Pharma Ltd.,Onoda Plant Tanabe Factory Domperidone Dr.Reddy's Laboratories Limited (Unit-6) Mosapride Citrate Gasmotin The Suzuka Plant of Dainippon Sumitomo Pharma Co., Ltd. Bacillus Subtilis and Enterococcus Faecium Powder Hanmi Pharm. Co., Ltd. 15
( ) () ( /) Oryz-Aspergillus Enzyme And Pancreatin Tablet Combizym Daiichi Sankyo Europe GmbH Benidipine Hydrochloride Kyowa Hakko Kirin Co.,Ltd. Sakai Plant Benidipine Hydrochloride Coniel Kyowa Hakko Kirin Co.,Ltd. Fuji Plant Amlodipine Besylate Cadila Limited Healthcare Doxazosin ( ) Mesylate Extended Release Valsartan Amlodipine ( ) and Pfizer Pharmaceuticals LLC Novartis Pharma Stein AG Valsartan and Hydrochlorothiaz ide Co-Diovan Novartis Pharma Stein AG Nicergoline Tablet Nixo HUA SHIN CHEMICAL PHARMACEUTICAL WORKS CO.,LTD 2 Candesartan Cilexetil Blopress Takeda Pharmaceutical Company Limited, Osaka Plant Tirofiban Hydrochloride Aggrastat DSM Pharmaceuticals Inc Human albumin Behring CSL Behring GmbH 16
( ) () ( /) Albumin From human Plasma -20 Plasbumin-2 0 Talecris Biotherapeutics,Inc. Human Albumin -25 Plasbumin-2 5 Talecris Biotherapeutics,Inc. Microcrystalline (2 ) Cellulose(2% Micronized Silica JRS PHARMA OY Gel) Magnesium Oxide Dead Sea Bromine Company Ltd(Magnesia Products SBU) A ( ) Vitamin A Palmitate Powder BASF A/S X Iohexol Omnipaque GE Healthcare Ireland α- α- Lipoic Acid Hameln Pharmaceuticals GmbH Enteral (TPF-D) Nutritional Suspension(TPF- GLUCERNA ABBOTT LABORATORIES B.V. ( ) D) HCV 3.0 ELISA Test System with Enhanced SAVe Diagnostic Kit Ortho-Clinical Diagnostics Inc.(A Johnson & Johnson Company) ( for Antibody to Hepatitis C Murex S.A.(PTY) Ltd. Biotech ) Virus(Elisa) 17
3 75 39 36 36 20 1 15 3 3 8 2009 9 3 3 3.1 1.1 3.1 3.1 3.1 3.1 3.1 3.2 3.2 3.2 39 26 11 2 3 3 9 2009 9 3 3 1.1 3.1 3.1 3.1 18
3.1 3.1 3.1 3.2 3.2 3.1 3.2 3.2 4 49 35 14 14 ( 11 ) 12 1 1 10 2009 9 19
57 (25 ) 42 10 5 11 2009 9 Galiximab AVE0010 / 20