Navigation Links
Takeda Receives New Information on Alogliptin (SYR-322) NDA
Date:3/6/2009

OSAKA, Japan, March 6 /PRNewswire/ -- Takeda Pharmaceutical Company Limited today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.

Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin's Prescription Drug User Fee Act (PDUFA) date - June 26, 2009 - remains unchanged.

In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes".

In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date -- October 27, 2008 -- due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.

Alogliptin, which was discovered by Takeda's wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.

About DPP-4 Inhibitors

DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase IV (DPP-4), which metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide
'/>"/>

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Healthcare Businesswomens Association Announces 2009 Woman of the Year, Dr. Deborah Dunsire, President and CEO of Millennium: The Takeda Oncology Company
2. Welvista Announces Partnering with Takeda to Provide Medication at No Cost to the Uninsured
3. Review of Takedas Febuxostat New Drug Application Continues Past PDUFA Date
4. FDA Adds Three Months to Review of Takedas New Drug Application for TAK-390MR
5. Takedas investigational PPI TAK-390MR demonstrated higher healing rates compared to lansoprazole
6. Takeda Completes Acquisition of Millennium
7. Takeda Commences Cash Tender Offer for all Outstanding Shares of Millennium
8. Takeda, Abbott Announce Plans to Conclude TAP Joint Venture
9. Takeda Announces New U.S. Leadership
10. Takeda submits new drug application for alogliptin (syr-322) in the US
11. Chemizon Announces Research Collaboration Expansion With Takeda
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/23/2014)... has recently announced that its Special Friday Shoes sales, ... offer will provide ladies many gorgeous shoes at greatly discounted ... women’s dresses retailers, and its shoes include many models in ... that day: Everything at Tbdress.com is up to 90% off. ... People can use the following coupon codes as well: , ...
(Date:11/23/2014)... 21, 2014 (HealthDay News) -- Close friends have more ... group does, a new study says. "We,ve ... have an influence on individual alcohol use, but there ... peer group and the friend group,s influence on those ... School of Public Health, said in a university news ...
(Date:11/23/2014)... This evaluation provides a basic conclusion ... and manufacturing technological innovation. Then, the evaluation investigates ... in information. In this part, the evaluation provides ... and 2009-2014 market shares for each company. Through ... and Chinese suppliers finish market of Femoral Occurs ...
(Date:11/23/2014)... 23, 2014 More than two dozen ... a federal litigation involving Byetta lawsuits ( http://www.byettalawsuit2013.com/ ), ... Liebhard LLP reports. , A Case List updated ... class of Type 2 diabetes medications referred to as ... District Court, Southern District of California, where a federal ...
(Date:11/23/2014)... DC (PRWEB) November 23, 2014 “BlackVue” ... Tech Report , which features the latest and ... technology expert and reporter for NewsWatch, conducted the product ... are unique and powerful options in the car camera ... rising and it can be hard to find the ...
Breaking Medicine News(10 mins):Health News:Tbdress.com Special Friday Shoes Sales Online Now 2Health News:Close Friends May Be Key to Teens' Drinking 2Health News:Femoral Stems Industry 2014 Analysis & 2019 Forecasts for Global and Chinese Region in New Research Report at ReportsnReports.com 2Health News:Femoral Stems Industry 2014 Analysis & 2019 Forecasts for Global and Chinese Region in New Research Report at ReportsnReports.com 3Health News:Femoral Stems Industry 2014 Analysis & 2019 Forecasts for Global and Chinese Region in New Research Report at ReportsnReports.com 4Health News:California Federal Court Overseeing Byetta Lawsuits, Other Incretin Mimetic Claims Adds New Cases in November, Bernstein Liebhard LLP Reports 2Health News:California Federal Court Overseeing Byetta Lawsuits, Other Incretin Mimetic Claims Adds New Cases in November, Bernstein Liebhard LLP Reports 3Health News:California Federal Court Overseeing Byetta Lawsuits, Other Incretin Mimetic Claims Adds New Cases in November, Bernstein Liebhard LLP Reports 4Health News:A Leader in Front and Rear Facing In-Car Cameras was Featured on NewsWatch Television on October 30, 2014 2
... The distinctive ability of mothers to identify the cries ... is critical to the survival of these offspring. In ... to recognize and respond to the smiles and cries of ... and social development of these babies. We have had ...
... Tips for using the full line of dermatologist ... The Theraplex Company, the,makers of a full line ... range of dry skin conditions, is launching its ... and advice for,healthy looking and beautiful skin. Four ...
... Schizophrenia emerges from an altered pattern of brain development, ... cause the brain to develop along a path that ... article to be published in Biological Psychiatry on March ... link to schizophrenia. , A prior genetic mapping study ...
... TotalLook MammoAdvantage(TM)Provides Enhanced Image Quality, Customization ... and Workflow Benefits to Mammography ... Inc. (Nasdaq:,ICAD), an industry-leading provider of Computer-Aided Detection ... announced the,availability of the TotalLook MammoAdvantage system which ...
... can used to diagnose severity of bipolar illness , , ... blood associated with mood disorders have been identified by ... finding may change the way bipolar illness is diagnosed ... 96 patients and found varying levels of the biomarkers ...
... renters told Apartments.com, during national heart, awareness month, ... of on-site fitness facilities offered ... The majority of renters lead a healthy,lifestyle by eating ... would also,prefer to step up their current workout routine ...
Cached Medicine News:Health News:Maternal love: How a mother's brain responds to her infant 2Health News:Prepare to Unveil Yourself with Theraplex(R) for Spring and Summer 2008 2Health News:Prepare to Unveil Yourself with Theraplex(R) for Spring and Summer 2008 3Health News:Prepare to Unveil Yourself with Theraplex(R) for Spring and Summer 2008 4Health News:New genetic association with schizophrenia found by researchers 2Health News:iCAD Introduces Next-Generation TotalLook Film Digitizer 2Health News:iCAD Introduces Next-Generation TotalLook Film Digitizer 3Health News:Biomarkers for Mood May Alter Psychiatric Treatments 2Health News:National Survey Reveals Most Renters Want What They Do Not Have: On-Site Workout Facilities 2
(Date:11/21/2014)... 21, 2014 Clementia Pharmaceuticals, ... Agency (EMA) has granted Orphan Medicinal Product ... candidate, for the treatment of fibrodysplasia ossificans ... disabling genetic disease characterized by painful, recurrent ... new abnormal bone formation. This process, known ...
(Date:11/21/2014)... Ontario , Nov. 20, 2014  RedRick ... mounting solutions and reading room environment guidance, has ... newest musculoskeletal radiology reading room, which may also ... designs at Penn Medicine. "In ... the American College of Radiology,s Imaging 3.0 ™ ...
(Date:11/21/2014)...   Coqui RadioPharmaceuticals Corp. , a medical isotope ... of Molybdenum-99 (Mo-99), is proud to announce it has ... design its Medical Isotope Production Facility (MIPF) in ... isotope of Technetium-99, which is used in 80 percent ... legislation making it a national priority to produce Mo-99, ...
Breaking Medicine Technology:Clementia Pharmaceuticals Receives EMA Orphan Medicinal Product Designation for Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva 2Clementia Pharmaceuticals Receives EMA Orphan Medicinal Product Designation for Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva 3RedRick Technologies Helps Penn Radiology Implement New Radiology Reading Room Concepts 2RedRick Technologies Helps Penn Radiology Implement New Radiology Reading Room Concepts 3Coqui RadioPharmaceuticals Inks Deal With INVAP 2
... Del., May 14, 2012  Synchrogenix Information Strategies Inc., a ... to announce the addition of a new office in ... Synchrogenix CEO, Ellen Barrosse, has appointed Bengt Olsson ... company,s newest office, located in Stockholm, Sweden.  With more ...
... 14, 2012  Eli Lilly and Company (NYSE: LLY ... its clinical oncology pipeline during the 48th Annual Meeting of ... Ill. from June 1 – 5, 2012. ... late-stage development to treat various types of cancer. The company ...
Cached Medicine Technology:Lilly Oncology To Disclose New Pipeline Data At ASCO 2012 2Lilly Oncology To Disclose New Pipeline Data At ASCO 2012 3Lilly Oncology To Disclose New Pipeline Data At ASCO 2012 4
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: