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紫铃风醉铁杆木虫 (正式写手)
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PDUFA Date 2015-FDA Calendar 1st Edition-持续更新，欢迎补充。 已有3人参与
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 格式： FDA Calendar Date Drug Name (Application Type) Indication Company (Ticker) Notes Press Release Q4 2014 12/03/2014 FDA根据Accelearted Approval Program批准了Amgen原PDUFA date为05/19/2015的Blinatumomab，用于ALL二线治疗。 (12/03/2014 Approved) 05/19/2015 Blinatumomab (BLA) ALL Amgen (AMGN) PDUFA/ Priority Review/ Accelerated Approval approved/ Breakthrough Therapy Designation/ Orphan Drug http://wwwext.amgen.com/media/me ... p;releaseID=1975963 http://wwwext.amgen.com/media/me ... p;releaseID=1994704 (12/04/2014 Approved)12/05/2014 Ruxolitinib (sNDA) Polycythemia vera Incyte (INCY) PDUFA/ Fast Track/ Priority Review/ Orphan Drug http://investor.incyte.com/phoen ... &highlight= http://investor.incyte.com/phoen ... &ID=1995014 12/17/2014 Meningococcal vaccine group B (BLA) Meningococcal group B infections Novartis (NVS) Priority Review/ Breakthrough Therapy Designation http://www.novartis.com/newsroom ... /2014/1793710.shtml 12/21/2014 Ceftolozane/ Tazobactam (NDA) cUTI and cIAI Cubist (CBST) PDUFA/ Fast Track /Priority Review http://www.cubist.com/media/news ... ceftolozane-tazobac 12/21/2014 Ombitasvir/ Paritaprevir/ Ritonavir (NDA) HCV AbbVie (ABBV) Priority Review/ Breakthrough Therapy Designation http://ir.enanta.com/phoenix.zht ... &ID=1992376 12/23/2014 Peramivir (NDA) Influenza virus infections Biocryst (BCRX) PDUFA/ Fast Track http://files.shareholder.com/dow ... 25_General_News.pdf 12/30/2014 Ivacaftor (sNDA) Cystic fibrosis Vertex (VRTX) PDUFA/ Fast Track/Priority Review/ Breakthrough Therapy Designation http://investors.vrtx.com/releasedetail.cfm?ReleaseID=877383 12/30/2014 Aspirin/ omeprazole 81/40 (Class 2 resubmission of NDA) Cardiovascular disorders (secondary prevention in patients at risk of aspirin-induced gastric ulcers) Pozen (POZN) PDUFA http://investors.pozen.com/phoen ... &ID=1947879 Q1 2015 Expected in Q1 2015 Asenapine (sNDA) Bipolar I Disorder Actavis (ACT) PDUFA/ Priority Review http://www.actavis.com/news/news ... e-of-snda-for-saphr 01/03/2015 Olaparib (NDA) Ovarian cancer AZ (AZN) PDUFA/ Priority Review/ Accelerated Approval denied/ Orphan Drug http://www.astrazeneca.com/Media ... f-year-results-2014 01/09/2015 Levodopa/carbidopa extended-release capsules (NDA) Parkinson\\\'s disease Impax (IPXL) PDUFA http://investors.impaxlabs.com/M ... 9-2015/default.aspx 01/21/2015 Perindopril/ amlodipine (NDA） Hypertension Symplmed PDUFA http://www.symplmed.com/symplmed_news_june_17_2014/ 01/24/2015 Parathyroid hormone (BLA) Hypoparathyroidism NPS (NPSP) PDUFA/ Orphan Drug http://ir.npsp.com/releasedetail.cfm?ReleaseID=877954 01/24/2015 Soluble ferric pyrophosphate (NDA) Iron deficiency anaemia Rockwell (RMTI) PDUFA http://ir.rockwellmed.com/releasedetail.cfm?ReleaseID=875372 01/31/2015 Fibrinogen/thrombin dry powder (BLA) Surgical blood loss Medicines Co. (MDCO) PDUFA http://ir.themedicinescompany.co ... &ID=1982510 02/06/2015 Ranibizumab (sBLA) Diabetic retinopathy Roche (RHHBY) PDUFA/ Priority Review http://www.gene.com/media/press- ... eview-for-genentech 02/12/2015 Rufinamide (sNDA) Lennox-Gastaut Syndrome Eisai (4523.T) PDUFA/ Priority Review/ Orphan Drug http://www.eisai.com/news/news201461.html 02/22/2015 Lenalidomide (sNDA) Newly diagnosed multiple myeloma Celgene (CELG) PDUFA/ Fast Track/ Priority Review/ Orphan Drug http://ir.celgene.com/releasedetail.cfm?ReleaseID=861748 02/27/2015 Ivabradine (NDA) Chronic heart failure Amgen (AMGN) PDUFA/ Fast Track/ Priority Review http://wwwext.amgen.com/media/me ... p;releaseID=1967698 02/28/2015 Rifaximin (sNDA) Irritable bowel syndrome Salix (SLXP) PDUFA/ Priority Review/ Orphan Drug http://news.salix.com/press-rele ... 50mg-snda-treatment 03/05/2015 Bupivacaine liposome injectable suspension (sNDA) Anaesthesia Pacira (PCRX) PDUFA http://investor.pacira.com/phoen ... &id=1927998 03/08/2015 Isavuconazonium (NDA) Invasive aspergillosis (IA) and invasive mucormycosis (IM) Astellas (4503.T) PDUFA/ Fast Track/ Priority Review/ Orphan Drug http://newsroom.astellas.us/2014 ... vasive-Mucormycosis 03/30/2015 Riboflavin topical (resubmission of NDA) Keratoconus Avedro PDUFA/ Orphan Drug http://avedro.com/press_release/ ... neal-cross-linking/ 03/30/2015 Nivolumab (BLA) Malignant melanoma BMS (BMY) PDUFA/ Fast Track/ Priority Review/ Breakthrough Therapy Designation/ Orphan Drug http://news.bms.com/press-releas ... o-nivolumab-us-and- Q2 2015 Expected in Q2 2015 Eluxadoline (NDA) Diarrhea predominant Irritable Bowel Syndrome (IBS-D) Actavis (ACT) PDUFA/ Fast Track/ Priority Review http://www.actavis.com/news/news ... e-for-filing-of-nda 04/13/2015 Palbociclib (NDA) Breast Cancer Pfizer (PFE) PDUFA/ Priority Review/ Breakthrough Therapy Designation http://www.pfizer.com/system/fil ... se_dijf3lskdf0k.pdf 04/14/2015 Lenvatinib (NDA) Advanced thyroid cancer Eisai (4523.T) PDUFA/ Priority Review/ Orphan Drug http://www.eisai.com/news/news201460.html 04/30/2015 CCP-01 (NDA) Common cold/cough Vernalis (VER.L) PDUFA http://www.vernalis.com/media-ce ... nda-for-full-review Expected in 05/2015 Pneumococcal vaccine conjugate 13-valent (sBLA) Pneumococcal infections in older adults Pfizer (PFE) PDUFA/ Fast Track/ Accelerated Approval approved http://www.pfizer.com/system/fil ... se_dijf3lskdf0k.pdf 05/13/2015 ATX 101 (NDA) Subcutaneous fat disorders Kythera (KYTH) PDUFA http://www.kytherabiopharma.com/ ... ptance-of-atx-101-n Q3 2015 07/11/2015 Brexpiprazole (NDA) MDD and SCZ Lundbeck PDUFA http://investor.lundbeck.com/releasedetail.cfm?releaseid=872293 08/22/2015 Aripiprazole Lauroxil (NDA) SCZ Alkermes (ALKS) PDUFA http://phx.corporate-ir.net/phoe ... &ID=1980168 08/27/2015 Evolocumab (BLA) Hypercholesterolaemia and Hyperlipoproteinaemia Amgen (AMGN) PDUFA/ Orphan Drug http://wwwext.amgen.com/media/me ... p;releaseID=1987861 |
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2014-12-04 21:15:39, 14.3 K
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2楼2014-12-05 08:32:40
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小木虫: 金币+0.5, 给个红包，谢谢回帖
小木虫: 金币+0.5, 给个红包，谢谢回帖
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楼主认真读过吗？我怎么发现个错误： 02/22/2015 Lenalidomide (sNDA) Malignant melanoma Celgene (CELG) PDUFA/ Fast Track/ Priority Review/ Orphan Drug http://ir.celgene.com/releasedetail.cfm?ReleaseID=861748 适应症不是Malignant melanoma（黑色素瘤）吧，应该是newly diagnosed multiple myeloma (新诊断的多发性骨髓瘤NDMM)吧。 |
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紫铃风醉3楼2014-12-05 10:30:57
紫铃风醉
铁杆木虫 (正式写手)
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4楼2014-12-05 12:42:31
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5楼2014-12-15 10:52:36