Navigation Links
Neurochem announces eprodisate (KIACTA(TM)) receives acknowledgement of complete response and is granted Class 2 review
Date:12/6/2007

ECUBLENS, Switzerland, Dec. 6 /PRNewswire-FirstCall/ - Neurochem (International) Limited (Neurochem), a wholly-owned subsidiary of Neurochem Inc. (NASDAQ: NRMX; TSX: NRM), announces that the Company has received an acknowledgement from the United States Food and Drug Administration (FDA) that Neurochem's response to the July 2007 approvable letter for the New Drug Application (NDA) for eprodisate (KIACTA(TM)) for the treatment of Amyloid A (AA) amyloidosis is a complete, Class 2 response. The PDUFA (Prescription Drug User Fee Act) goal date by which the FDA is expected to render a decision is April 2, 2008.

The NDA for approval of eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis was filed in February 2006. The Company submitted its response to the second approvable letter last September and this response has been acknowledged as complete by the FDA, allowing for the Class 2 review.

"We look forward to further productive interactions with the FDA as we enter late-stage discussions on our marketing application," said Dr. Francesco Bellini, Neurochem Inc.'s Chairman, President and CEO.

About eprodisate (KIACTA(TM))

Eprodisate (KIACTA(TM)) was investigated in an international, randomized, double-blind, placebo-controlled, and parallel-designed Phase II/III clinical trial in which 183 AA amyloidosis patients were enrolled at 27 sites around the world (Eprodisate for AA Amyloidosis Trial, EFAAT). Patients who completed the clinical trial were eligible for enrollment in an ongoing open-label extension study, some of whom have now been receiving eprodisate (KIACTA(TM)) for more than six years.

In September 2006, the European Medicines Agency (EMEA) confirmed that it had commenced
'/>"/>

SOURCE NEUROCHEM INC.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Neurochem reports results for third quarter of fiscal 2007
2. Neurochem announces departure of Dr. Philippe Calais, President, Global Business
3. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
4. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
5. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
6. HEI, Inc. Announces Sale of RFID Division Assets
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
8. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
9. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
10. Brooke Franchise Corporation Announces Selected July Results
11. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has ... View website of AngelWeddingDress.com to find more ... dresses online for a bridal party. AngelWeddingDress offers a ... them. Its maternity wedding dresses are specially designed for ...
(Date:1/22/2015)... Autocarinsurancebest.com has released a new blog post explaining the ... . , Auto insurance quotes help many drivers find ... necessary to call an agent or visit an agency for ... single website: http://autocarinsurancebest.com/ . , Every business who relies ...
(Date:1/22/2015)... 2015 Yesterday, Senator Holly Mitchell ... Kristin Olsen (R-Modesto) were honored by the California ... biotechnology, biomedical science, medical device and pharmaceutical innovation ... the “2014 Life Sciences Champion” award from CHI ...
(Date:1/22/2015)... January 22, 2015 EBSCO Information Services ... are expanding their relationship in an effort to further promote ... world. While EBSCO has long made AMA journals available via ... agent for The JAMA Network. , Long known ...
(Date:1/22/2015)... Step into a macabre world where ... of Virginia. Wicked Plants, the Museum’s latest featured exhibition, ... poisonous, carnivorous and diabolical plants inside of a dilapidated, ... the biochemical, physical and neurological processes between botanicals and ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4Health News:Wicked Plants are taking over the Science Museum of Virginia 2
... patients with coronary artery disease were almost three times ... interventional treatment to arterial plaque than their White European ... IJCP, the International Journal of Clinical Practice . ... emergency and require urgent treatment. Researchers carried out ...
... in sexual activity, the more likely they are to ... to new research presented in Boston at The Gerontological ... This finding is based on the 2004� General Social ... representative sample of non-institutionalized English and Spanish-speaking person 18 ...
... FRIDAY, Nov. 18 (HealthDay News) -- New research suggests that ... communicating via email or instant messages rather than when they ... What,s new is that we lie even more online," said ... at the University of Massachusetts-Amherst. In the study, the ...
... - IBM,s Watson computing system broke new ground earlier this ... Jeopardy! game show. Now, The Scripps Research Institute is hoping ... health with part of the prize money from that tournament: ... the public,s help. To that end, Scripps Research ...
... at the University of California, San Diego School of Medicine ... colleagues in Boston and South Korea, say they have identified ... of glioblastoma (GBM), the most common type of malignant brain ... online edition of the journal Cancer Research . ...
... 2011 - The Canadian Diabetes Association is pleased to ... Elsevier to publish the Canadian Journal of Diabetes ... CJD is Canada,s only diabetes-oriented, peer-reviewed, interdisciplinary ... the sharing and enhancement of knowledge to advance the ...
Cached Medicine News:Health News:South Asian patients require 3 times as much repeat angioplasty as white Europeans 2Health News:South Asian patients require 3 times as much repeat angioplasty as white Europeans 3Health News:Study finds sex a significant predictor of happiness among married seniors 2Health News:People May Lie More Often in Emails, Instant Messages 2Health News:Jeopardy! winnings spur IBM and Scripps Research Institute collaboration to fight against malaria 2Health News:Jeopardy! winnings spur IBM and Scripps Research Institute collaboration to fight against malaria 3Health News:Old drugs find new target for treating brain tumor 2Health News:Old drugs find new target for treating brain tumor 3
(Date:1/23/2015)... , Jan. 23, 2015  MedScope ( www.medscope.org ), the ... for a 2015 Connected World magazine Connected ... System (mPERS), that can be used anywhere, anytime. The ... In nominating MedScope, Landon Garner ...
(Date:1/23/2015)... Rose, baseball,s all-time hits leader, is the new spokesperson for ... Pharma has announced. "Pete,s a Hall of Famer ... on board with Myoflex," said Ducere Pharma Chief Executive Officer ... is known across all generations. The passion and intensity that ...
(Date:1/23/2015)... , Jan. 23, 2015  Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT), ... I trial of Lixte,s lead compound, LB‑100, is being conducted, ... John S. Kovach , M.D., the founder and President ... be completed at a single site. Accrual of patients, however, ...
Breaking Medicine Technology:MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2Pete Rose bets on Myoflex to relieve aches and pains 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3
... Denali Concrete Management Inc. (OTCBB: DCMG) announced today ... acquisition of Denali by Can-Fite BioPharma Ltd. (TASE: CFBI) ... outstanding shares of EyeFite Ltd., a private company incorporated ... exclusive license over CF101 for ophthalmic indications. Concurrently, Denali ...
... 22, 2011 Par Pharmaceutical Companies, Inc. (NYSE: ... approved the promotions of Thomas J. Haughey to the role ... Chief Operating Officer of the Company and its subsidiaries, effective ... LePore who will retain his title of Chairman of the ...
Cached Medicine Technology:Denali Concrete Management Inc. Announces its Acquisition of CF101 for Ophthalmic Indications and the Completion of Above $6 Million Private Placement at $1.144 Per Share 2Denali Concrete Management Inc. Announces its Acquisition of CF101 for Ophthalmic Indications and the Completion of Above $6 Million Private Placement at $1.144 Per Share 3Par Pharmaceutical Companies Promotes Thomas J. Haughey to President and Paul V. Campanelli to Chief Operating Officer 2
Used for dilation of a tract to the kidney for removal of stones. Supplied sterile in peel-open packages. Intended for one-time use....
... supplied on Smart Cards. Insert the card and ... and turns itself off after the programmed time. ... duration of treatments. Simply provide your patient with ... their progress on the next visit.,The initial set ...
... painfree therapy stimulates the spincter and ... contractions and relaxation. By use of ... surgical operations (bladder liftings) may be ... can improve unsatisfying results. DETRUSAM intravesical ...
... ELPHA 4 Conti is a battery operated ... treatment of conditions described below. ELPHA 4 Conti ... In STRESS- and faecal incontinence ELPHA 4 Conti ... that the user can feel which muscles need ...
Medicine Products: