Navigation Links
Cipher reports third quarter fiscal 2007 results
Date:11/7/2007

eeks to build its presence in the important primary care space.

During the second quarter of 2007, Cipher received a second approvable letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the FDA indicated that Cipher's application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls, which the Company has responded to, the FDA has requested that Cipher provide additional clinical safety data. The Company appealed the position taken by the FDA in its approvable letter using the formal dispute resolution process. Cipher submitted its appeal and met with the FDA on July 11, 2007. In August 2007, the Company received a response from the FDA to its request for formal dispute resolution. In the letter to Cipher, the representative from the FDA agreed with the Division of Dermatology and Dental Product's view that a clinical study is needed to further demonstrate the safety of CIP-ISOTRETINOIN. Subsequently, Cipher has had further discussions with the FDA on the issues raised in its response letter. Cipher continues to believe that the clinical questions raised by the FDA have been addressed in the NDA submission. The appeal process is ongoing.

During the second quarter of 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's once-daily formulation of tramadol. In its letter, the FDA indicated that Cipher's application is approvable subject to the resolution of certain issues, including a request for an additional adequate clinical trial to provide further efficacy data. In subsequent discussions with the FDA, Cipher has obtained clarification on the question of efficacy. The FDA has indicated that the statistical methods used to analyze data from Cipher's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials. The Company has a meeting sched
'/>"/>

SOURCE Cipher Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Related medicine news :

1. New Study Reports High Injury Rates for Hotel Workers, Even Higher Rates for Women and Nonwhites
2. Haemacure Reports Third Quarter 2007 Results
3. First-Ever List of the 5,000 Fastest-Growing Businesses Reports Total Revenue of $194.5 Billion
4. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best
5. MDS Reports Third Quarter 2007 Results
6. Allied Healthcare Reports Strong Fourth Quarter, Flat Net Income for Fiscal 2007 vs. 2006
7. AtriCure Reports First Human Implant of the Cosgrove-Gillinov Left Atrial Appendage Occlusion System
8. NMHC Reports Fourth Quarter and Fiscal Year 2007 Financial Results
9. Blue Cross and Blue Shield of Florida Reports Eighteenth Consecutive Year of Positive Performance
10. ReBuilder Medical Technologies, Inc. Reports International Sales Expansion
11. AdCare Health Systems, Inc. Reports Discontinuation of Definitive Merger Agreement with Family Home Health Services, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/4/2015)... Christopher Asandra, M.D., Founder and Chief Medical Officer of ... recent decision to issue a warning on testosterone ... are not supported by science, and that the warning ... “The FDA appears to have developed a case of ... “There is not nearly enough evidence to support the ...
(Date:3/4/2015)... TROY Healthcare Solutions will be introducing TROY ... level of security for prescriptions, in Houston, Texas on ... Center located at 6633 Travis Street from 7 AM ... TROY Healthcare Solutions will host a continental breakfast. Starting ... presentations each hour to introduce attendees to TROY Secure ...
(Date:3/4/2015)... 04, 2015 Cook For Your Life ... teaches healthy cooking to people touched by cancer, is ... The program, run by founder Ann Ogden, will be ... Management. The unique partnership will expand the program from ... CFYL in 2007. After going through her own cancer ...
(Date:3/4/2015)... (PRWEB) March 04, 2015 Smokers across ... marketing campaign called 'We Love Smokers' from Aqua-Tine, the ... tobacco. , "It’s important to establish a clear ... to it. Our idea, 'We Love Smokers' elevates the ... of view. We created a bold tone of voice ...
(Date:3/4/2015)... Blake’s All Natural Foods , ... attend this year’s Natural Products Expo West in Anaheim, ... this new line, Blake’s, who has the top four ... its commitment to creating high-quality dishes that are easily ... the natural channel, Blake’s understands what educated consumers are ...
Breaking Medicine News(10 mins):Health News:NuMale’s Dr. Christopher Asandra: FDA Suffering from “Premature Equivocation” on Issue of Testosterone and Risks 2Health News:TROY Healthcare to Offer Prescription Solutions that can save a Hospital $100,000 2Health News:TROY Healthcare to Offer Prescription Solutions that can save a Hospital $100,000 3Health News:Drexel University and Cook for Your Life Team Up 2Health News:Drexel University and Cook for Your Life Team Up 3Health News:Drexel University and Cook for Your Life Team Up 4Health News:Drexel University and Cook for Your Life Team Up 5Health News:The Brand Behind The Bold and Provocative Ad Campaign 'We Love Smokers' 2Health News:The Brand Behind The Bold and Provocative Ad Campaign 'We Love Smokers' 3Health News:Fastest Growing Frozen Brand in Natural Channel Showcases New Line at Expo West 2015 2Health News:Fastest Growing Frozen Brand in Natural Channel Showcases New Line at Expo West 2015 3
... some students experience while taking their exams may also affect ... allergy// , scientists say. ,Mats Lekander and other ... medical exam affects stress hormone levels, the immune system and ... ,The extensive tests were conducted on two occasions - first ...
... death toll from the ‘Typhoon Saomai’ has risen to 330. ... had increased// after 6 more bodies were discovered in the ... bodies were fished out from the sea, off the Shacheng ... 186. ,Cai Meisheng, vice mayor of Fuding, said ...
... eyesight, but according to a recent research, yellow and green vegetables ... be good for the eyesight. ,The diets of 1,700 American ... researchers at the University of Wisconsin to observe the affect of ... carried out by asking each woman what was her regular diet ...
... that getting married may benefit depressed people more than it ... beneficial to the general well being of a person, but ... health aspect of tying the knot. ,“Our findings question ... for all individuals,” observed co-author Adrianne Frech, a doctoral student ...
... child attending the Craigneuk Nursery Centre in Wishaw is recovering at ... O157 infection. ,The Craigneuk Nursery Centre cares for ... ,A NHS Lanarkshire, spokesman who refused to reveal ... children had been contacted as a precaution. ,A ...
... has touched the 25 year mark and this year ... With increasing// access to lifesaving treatments last year even ... reported declining HIV infection rates. However Bill Gates addressing ... that current trends don’t bode well for the future ...
Cached Medicine News:Health News:Yellow and green vegetables for better eyesight 2Health News:Need for Change in Social Norms to Prevent Spread of HIV 2Health News:Need for Change in Social Norms to Prevent Spread of HIV 3
(Date:3/4/2015)... Products, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), ... today announced its financial results for the fourth quarter ... 2014 Financial Highlights , Total sales in ... 36.8% excluding the impact of foreign currency exchange rate ... same quarter of 2013. , Gross profit increased ...
(Date:3/4/2015)... Mass., March 4, 2015 GSI Group Inc. ... "GSI"),  a global leader and supplier of precision photonics ... equipment and advanced industrial technology markets, today reported financial ... Unless otherwise noted, all financial results in this press ... Fourth QuarterDuring the fourth quarter of 2014, GSI ...
(Date:3/4/2015)... -- Alimera Sciences, Inc. (NASDAQ: ALIM ... the research, development and commercialization of prescription ophthalmic ... quarter and year ended December 31, 2014. ... for Alimera Sciences, most notably having received U.S. ... treatment of diabetic macular edema," said Dan Myers, ...
Breaking Medicine Technology:China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 2China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 3China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 4China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 5China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 6China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 7China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 8China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 9China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 10China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 11China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 12China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 13China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 14China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 15China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 16China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 17China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 18China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 19China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 20China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 21China Biologic Reports Financial Results for the Fourth Quarter and Fiscal Year 2014 22GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 2GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 3GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 4GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 5GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 6GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 7GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 8GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 9GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 10GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 11GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 12GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 13GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 14GSI Group Announces Financial Results for the Fourth Quarter and Full Year 2014 15
... of Disease Activity as Measured,by MRI and Relapse ... May 1, 2007 -- Genentech, Inc.,(NYSE: DNA) ... from a Phase II clinical study of Rituxan®,(rituximab) in ... the American Academy of Neurology,annual meeting held in Boston. ...
... BOSTON--(BUSINESS WIRE)--May 1, 2007 - Significantly more patients,treated ... percent or,more compared with placebo, according to study ... annual meeting.,Clinically, this outcome would equate to a ... to moderate pain., Fibromyalgia is one of the ...
Cached Medicine Technology:Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 2Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 3Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 4Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 5Rituxan Phase II Data in Patients with Relapsing-Remitting Multiple,Sclerosis Presented at the American Academy of Neurology 6Lyrica Significantly Reduced Pain and Helped Patients Manage the,Symptoms of Fibromyalgia, Data Show 2Lyrica Significantly Reduced Pain and Helped Patients Manage the,Symptoms of Fibromyalgia, Data Show 3
Straight shafts with 4 mm platform. Wide serrated handle with dull finish. Platform straight....
Regular tip. 1 mm x 13 mm. Serrated. Insulated....
Straight shafts with fine tips and dull finish. Insulated stop with tip gap set at 0.3 mm. Smooth handle....
Curved shafts with 3.5 mm angled platform and dull finish. Wide serrated handle with dull finish....
Medicine Products: