Navigation Links
BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
Date:5/6/2010

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., May 6, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We will continue to work closely with the agency through this final stage of the review process."

The new drug application (NDA) for BYDUREON was submitted in May 2009 and was based on data from the DURATION clinical trial program, as well as more than seven years of clinical experience with BYETTA® (exenatide) injection. The agency issued a complete response letter to the companies in March 2010 and the companies responded to that letter in April 2010.

BYDUREON (pronounced by-DUR-
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
2. Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory Panel
3. Amyris Biotechnologies Co-Founder Neil Renninger Named to Technology Reviews Prestigious TR35 List of Top Young Innovators
4. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiogaphic Data Safety Monitoring Board Review
5. Arena Pharmaceuticals Continues Phase 3 BLOOM Obesity Trial Following Independent Echocardiographic Data Safety Monitoring Board Review
6. AEterna Zentaris Announces Outcome of Managements Strategic Review
7. Thomson Scientific Publishes Who Is Making The Biggest Splash? - A Quarterly Review of Scientific Literature on Drugs and Therapies From April - June 2007
8. BioMS Medicals relapsing-remitting multiple sclerosis trial receives positive review from Data Safety Monitoring Board
9. Neurobiological Technologies, Inc. (Nasdaq: NTII) Q1/08 Review Issued By Scimitar Equity Research, Inc.
10. BioMS Medicals phase III U.S. multiple sclerosis trial receives positive safety review from Data Safety Monitoring Board
11. BioMS Medicals pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/26/2014)... -- Theravalues Corporation annuncia con orgoglio il lancio di ... Hi Europe 2014 (dal 2 al 4 dicembre, ... curcumina con la maggiore biodisponibilità di sempre, con una ... dalle norme europee. La curcumina è un ... Curcuma longa ) che è stata associata con attività ...
(Date:11/24/2014)... BUENA, N.J. , Nov. 24, 2014  IGI ... Jersey based specialty generic pharmaceutical company, today ... application (ANDA) to the U.S. Food and Drug Administration ... submissions in 2014 to seven, with eighteen submissions now ... Grenfell-Gardner , President and CEO of the Company, commented, ...
(Date:11/24/2014)... , Nov. 24, 2014  Last week, Representatives ... Butterfield (D-NC) took a bold bipartisan step ... introducing the OPEN Act. Original co-sponsors of the ... The Act will incentivize drug makers and innovators ... diseases and pediatric cancers, which opens the door ...
(Date:11/24/2014)... 2014   First ... Elsevier , a world-leading provider of scientific, ... announce the launch of the latest title in the ... in Food Science . ... a new platform to keep up-to-date with the expanding volume ...
Breaking Biology Technology:La curcumina con la maggiore biodisponibilità di sempre farà il suo debutto in Europa 2La curcumina con la maggiore biodisponibilità di sempre farà il suo debutto in Europa 3IGI Laboratories, Inc. Announces ANDA Submission 2OPEN Act Introduced to Repurpose Drugs for Rare Diseases 2Elsevier Announces Launch of New Journal: Current Opinion in Food Science 2Elsevier Announces Launch of New Journal: Current Opinion in Food Science 3
... Inclinix, Inc. has announced today that it has ... (Nasdaq: DATA ) to offer the most ... device companies globally. , ... DATATRAK,s eClinical(TM) platform to enhance its services as a ...
... Md., April 30 /PRNewswire/ -- ... company developing novel, proprietary antibodies for the treatment of ... will host a conference call and audio webcast on ... (3:00 pm Central European Time) to discuss its financial ...
... Inc. (NASDAQ: AEZS , TSX: AEZ), a ... will announce its first quarter 2009 financial and operating ... The Company will host a conference call and webcast ... 3:30 p.m., Eastern Time. , Participants may access the ...
Cached Biology Technology:DATATRAK International, Inc. Forms Strategic Partnership with Inclinix, Inc. 2DATATRAK International, Inc. Forms Strategic Partnership with Inclinix, Inc. 3DATATRAK International, Inc. Forms Strategic Partnership with Inclinix, Inc. 4Micromet, Inc. to Host Conference Call and Webcast to Report First Quarter 2009 Financial Results on May 6, 2009 2Micromet, Inc. to Host Conference Call and Webcast to Report First Quarter 2009 Financial Results on May 6, 2009 3Micromet, Inc. to Host Conference Call and Webcast to Report First Quarter 2009 Financial Results on May 6, 2009 4
(Date:11/4/2014)... , November 4, 2014   ... vertical market growth   Fuel3D , a ... closed a funding round totaling $6.4 million (£4 million). This ... funding secured earlier this year and paves the way for ... 2015. The funding round was led by Chimera ...
(Date:11/4/2014)... Lithuania , Nov. 4, 2014   ... technologies, today announced that the latest version of ... in the Ongoing MINEX evaluation organized ... of fingerprint algorithms using the INCITS 378 fingerprint ... mandatory requirement in public tenders in ...
(Date:11/3/2014)... Cancer Center study published in this month,s ... describes the activity of a recently discovered communication molecule ... It has been known to limit inflammation and the ... system: IL-37 inhibits the ability of the immune system ... mechanism that underlies IL-37,s effect on the immune system ...
Breaking Biology News(10 mins):Fuel3D Secures $6.4 Million in Expansion Funding 2Fuel3D Secures $6.4 Million in Expansion Funding 3Neurotechnology Places Second in Ongoing MINEX Ranking for Fingerprint Matching Algorithms 2Neurotechnology Places Second in Ongoing MINEX Ranking for Fingerprint Matching Algorithms 3PNAS: From HIV to cancer, IL-37 regulates immune system 2
... Studies on genetically engineered mice show that social stress ... atherosclerosis. Commonly used drugs to reduce blood pressure, however, ... a thesis presented at the University of Gothenburg, Sweden. ... is a correlation between psychosocial stress and the risk ...
... heart defects has been identified by a team of scientists, ... to new treatments for those affected by the conditions brought ... on identifying and studying the gene in zebrafish embryos, and ... studying the genetics of mice and people. "This ...
... 6, 2010 Parascript, LLC, the image analysis ... its Signature Xpert was awarded best performance ... Conference on Frontiers in Handwriting Recognition (ICFHR2010) in ... Parascript was among seven participants representing a total ...
Cached Biology News:Social stress leads to atherosclerosis 2Scientists find gene linked to congenital heart defect 2Scientists find gene linked to congenital heart defect 3Scientists find gene linked to congenital heart defect 4Parascript SignatureXpert Wins Forensic Signature Verification Competition 2
Designed for flow cytometric applications intended to identify...
MOUSE ANTI RAT RT1Bu / MOUSE Ia:BIOTIN Immunogen: Rat thymocyte membrane glycoproteins...
MOUSE ANTI GUINEA PIG T-CELLS (PAN):FITC Immunogen: Guinea pig peritoneal T-cells...
MOUSE ANTI RABBIT T LYMPHOCTYES Immunogen: Rabbit Thymocytes...
Biology Products: