Navigation Links
Indevus Receives Approvable Letter from FDA for NEBIDO(R)
Date:6/30/2008

Company Announces Revised Operating Plan to Respond to NEBIDO Delay

LEXINGTON, Mass., June 30 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product. The letter generally confirmed the Company's previously-announced indications from the FDA based on telephone discussions.

The FDA has expressed a concern about a relatively small number of patients in European post-marketing use who have experienced respiratory symptoms immediately following the intramuscular injection of NEBIDO 1000 mg, 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used in the United States). The Company believes and the FDA concurs that the reaction is likely the result of a small amount of the oily solution immediately entering the vascular system from the injection site, a known, rare complication of oil-based depot injections.

The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting. In the Company's U.S. clinical trials of NEBIDO 750 mg (3 cc injection volume), the proposed dose in the U.S., there was a single, mild, non-serious case of oil-based cough observed. In addition, the FDA believes that four cases in the European post-
'/>"/>

SOURCE Indevus Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Indevus Announces Management Changes
2. Indevus Pharmaceuticals Scheduled to Present at Upcoming Investor Conferences
3. 125 Indevus Sales Representatives to Provide Community Service in New Orleans for Jericho Road Episcopal Housing Initiative
4. Indevus Pharmaceuticals to Present at Cowen and Company 28th Annual Health Care Conference
5. Indevus Comments on Bayer Healthcare Discontinuation of Viadur(R)
6. Indevus Receives Non-Approvable Letter From FDA for VALSTAR(TM)
7. Indevus Pharmaceuticals Announces Retirement of David B. Sharrock From Its Board of Directors
8. Indevus Announces Allergan as New Partner for SANCTURA Brand
9. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
10. Alfacell Receives NASDAQ Non-Compliance Notification
11. Albany College of Pharmacy Researcher Receives $368,445 Grant from the National Institutes of Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Davis, California (PRWEB) January 22, 2015 ... of Accelerator Mass Spectrometry (AMS) services to the pharmaceutical ... PhD has joined the company in the position of ... 30 years of broad and valuable experience in drug ...
(Date:1/22/2015)... RBJ today announces the firm brokered a long-term lease totaling ... biopharmaceutical company, at Two Ledgemont Center in Lexington, ... president, and Brian Cohen , senior vice president, represented ... 95 Hayden Ave. Photo - http://photos.prnewswire.com/prnh/20150122/170765 ...
(Date:1/22/2015)... RBJ today announces the firm brokered a long-term lease totaling ... biopharmaceutical company, at Two Ledgemont Center in Lexington, ... president, and Brian Cohen , senior vice president, represented ... 95 Hayden Ave. Photo - http://photos.prnewswire.com/prnh/20150122/170765 ...
(Date:1/22/2015)... The laboratory information management systems market ... number of technological advancements due to factors such as ... to integrate healthcare systems, and increasing government support for ... integration. Key players in the market focus on technological ...
Breaking Biology Technology:Eckert & Ziegler Vitalea Science appoints Mark Seymour, PhD as Director of Science & Technology 2Eckert & Ziegler Vitalea Science appoints Mark Seymour, PhD as Director of Science & Technology 3Transwestern | RBJ Advises Shire in 202,000 SF Lease, Creating Boston's Largest Suburban Biotech Campus 2Transwestern?RBJ Advises Shire in 202,000 SF Lease, Creating Boston's Largest Suburban Biotech Campus 2Laboratory Information Management Systems Market is Expected to Reach $1,323.6 Million by 2019 - New Research Report by MarketsandMarkets 2Laboratory Information Management Systems Market is Expected to Reach $1,323.6 Million by 2019 - New Research Report by MarketsandMarkets 3Laboratory Information Management Systems Market is Expected to Reach $1,323.6 Million by 2019 - New Research Report by MarketsandMarkets 4
... quarter of 2008 versus third quarter ... ... CRY ),a biomaterials, medical device and tissue processing company, announced,today that revenues ... to $22.2 million in the third quarter of 2007.,Excluding orthopaedic tissue processing ...
... Oct. 30 Human Genome,Sciences, Inc. (Nasdaq: HGSI ... to discuss its financial results for the quarter ended,September ... on Thursday,November 6, 2008, after the capital markets close., ... call will be hosted by senior management and will ...
... Pharmaceuticals,Inc. (Nasdaq: VNDA ), a biopharmaceutical company ... candidates for central,nervous system disorders, today announced financial ... 30, 2008., Vanda reported research and development ... $3.8 million, compared to $5.5 million in the ...
Cached Biology Technology:CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 2CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 3CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 4CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 5CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 6CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 7CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 8CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 9CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 10CryoLife's Fully Diluted Earnings Per Share Increased 71 Percent to $0.12 in Third quarter of 2008 from $0.07 in Third quarter of 2007 11Human Genome Sciences to Sponsor Conference Call to Discuss Third Quarter 2008 Financial Results 2Vanda Pharmaceuticals Reports Third Quarter 2008 Results 2Vanda Pharmaceuticals Reports Third Quarter 2008 Results 3Vanda Pharmaceuticals Reports Third Quarter 2008 Results 4Vanda Pharmaceuticals Reports Third Quarter 2008 Results 5Vanda Pharmaceuticals Reports Third Quarter 2008 Results 6Vanda Pharmaceuticals Reports Third Quarter 2008 Results 7Vanda Pharmaceuticals Reports Third Quarter 2008 Results 8Vanda Pharmaceuticals Reports Third Quarter 2008 Results 9Vanda Pharmaceuticals Reports Third Quarter 2008 Results 10
(Date:12/17/2014)... Markets ( http://www.researchandmarkets.com/research/9zq33j/global_chemical ) has announced the ... report to their offering. ... in this market is the increasing demand for medical ... of patient data for quick and correct diagnosis during ...
(Date:12/11/2014)... and Markets , http://photos.prnewswire.com/prnh/20130307/600769 ... the addition of the "Biometrics Market in India ... One major trend emerging in this market is the ... more than one characteristic of an individual for verification ...
(Date:12/10/2014)... , Dec. 9, 2014  Valencell, a leader in performance ... a staggering demand from its licensees for highly accurate, ... is not solely coming from fitness and health sectors, ... "A wearable is only as useful as the ...
Breaking Biology News(10 mins):Global Chemical Sensor Market 2015-2019: Key Vendors are Abbott Laboratories, Bayer, Hoffmann La-Roche, Johnson & Johnson, NGK Spark Plugs and Robert Bosch 2Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2Wearable Technology Products Demand Highly Accurate Biometric Technology 2
... is easy: we call it fire. But ... oxygen to a particular carbon atom in a complicated ... to an enzyme called cytochrome P450. Because cytochrome P450 ... been called "nature,s blowtorch," and its job is analogous ...
... issue of GEOSPHERE, published by the Geological Society ... interest include common ground in the disagreement between ... a USGS Great Basin Paleontological Database filled with ... terrestrial laser scanners and digital cameras in three-dimensional ...
... (EMBL) in Heidelberg, Germany, and the EMBL-European Bioinformatics Institute ... how sex chromosomes are regulated. A chromatin modifying enzyme ... one copy of the sex chromosome X, while females ... sex chromosomes in fruit flies and binds to different ...
Cached Biology News:A molecular switch turns on the flame in 'nature's blowtorch' 2June GEOSPHERE media highlights 2June GEOSPHERE media highlights 3June GEOSPHERE media highlights 4X chromosome exposed 2
... sensitive laser confocal systems designed for rapid ... that meet your expectations, differentiating between a ... the signal on the bottom as well ... for increased sensitivity. Results with VersArray ChipReader ...
... one plate. The new ArraySlide 96 chamber ... x 7mm) individual printing surfaces for multiple ... studies. Unlike other systems, this device utilizes ... of contaminating adhesives. The chamber itself is ...
Bio-Plex Manager software, version 3.0, 5 license netshare, is a five-user software package that provides access to data from the Bio-Plex suspension array system from a server. This version does not...
... Hyb-Seal slide chambers are vapor-tight adhesive chambers for ... chambers are affixed over a sample on a ... of two ports, and the ports are then ... removed and replaced to allow exchange of reaction ...
Biology Products: