Navigation Links
Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
Date:9/4/2009

DEERFIELD, Ill. and OSAKA, Japan, Sept. 4 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl). The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular (CV) safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."

"This complete response letter from the FDA is consistent with the June 26 complete response letter for alogliptin, a key component of the alogliptin and ACTOS fixed-dose combination product," said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. "The FDA recently agreed to the study design for a cardiovascular outcomes trial for alogliptin, titled EXAMINE, and patient enrollment is planned to begin this month. We anticipate that the EXAMINE trial will provide the FDA with the information needed to continue the NDA reviews of both the alogliptin monotherapy and the alogliptin and ACTOS fixed-dose combination."

The complete response letter was specific to the FDC of alogliptin and ACTOS, and did not include any new questions or concerns about alogliptin or ACTOS.

About ACTOS(R) (pioglitazone HCl)

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diab
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes
2. Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)
3. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
4. Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filings in Europe
5. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
6. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
7. Takedas Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed
8. Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
9. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
10. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
11. Cytopias CYT387 Receives FDA Clearance to Start US Clinical Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... LONDON , July 11, 2014 /PRNewswire/ ... of visitors to Safety & Health Expo ... by the move to London ... senior management attending exhibition.     ... (Photo: http://photos.prnewswire.com/prnh/20140711/696892-a ) ...
(Date:7/10/2014)... , 11. Juli 2014  Dilon ... für die molekulare Bildgebung, einschließlich molekularer ... die CE-Zulassung für sein Navigator ® ... Dilon das Produkt jetzt europaweit vertreiben. ... Großteil der europäischen Länder ausgedehnt und ...
(Date:7/10/2014)... , July 10, 2014 Integrated Silicon Solution, ... advanced memory and analog IC solutions, today announced that ... July 24, 2014, at 7:00 a.m. Pacific Time (10:00 ... for the fiscal 2014 third quarter ended June 30, ... telephone, dial 1-888-556-4997 before 6:50 a.m. Pacific time on ...
Breaking Medicine Technology:UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 2UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 3UK's Flagship Health & Safety Event Has Successful Inaugural Year in London 4Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2
... Extrovertic and Virilion ... , to help healthcare companies engage consumers in an increasingly ... ) , "Innovating to meet the perpetually evolving needs ... Dorothy Wetzel, co-founder and executive marketer at Extrovertic. "Doing it ...
... 28 Southern California-based philanthropy Free Wheelchair Mission ... Blessing International,s annual giving catalog. Called "Relief ... 19 humanitarian outreach operations, supporting causes including hunger ... , The two international nonprofits have collaborated since ...
Cached Medicine Technology:Joint Venture Formed to Help Health Marketers Navigate Social Media Environment 2OC-Based Charity Teams with International Relief Organization in Holiday Fundraising Drive 2
(Date:7/13/2014)... MarketsandMarkets recently conducted a study on ... 3D rendering; Layout and Animation; Image Reconstruction]: Global ... which analyzes and studies the major market drivers, ... Eastern Europe, Middle East and Africa, Asia-Pacific and ... landscape of the 3D imaging market, providing an ...
(Date:7/13/2014)... July 13, 2014 The Pearland, Texas location ... in age from four months to 12 years of age ... classes to birthday parties and Summer Camps, is now under ... Gym of Pearland after spending over six years at ... including Gym Director. , Berry has over ten years ...
(Date:7/13/2014)... 13, 2014 Recently, 2014QuinceaneraDresses.com, the ... unveiled its new range of gorgeous Quinceanera ... the demand for elegant Quinceanera outfits is huge. ... items. All the company’s newly released dresses are ... are all elegant and vivid. , It ...
(Date:7/13/2014)... 2014 Fadhits.com is popular among worldwide ... are extremely beautiful. Recently, the company has announced its ... 2014. What’s more, all these outfits are available at ... , Additionally, the supplier is now offering similar discounts ... dresses, it has many other designs for sale, including ...
(Date:7/13/2014)... COPENHAGEN, July 13, 2014 A decreased ability ... cognitive impairment and Alzheimer,s disease, while examinations of ... a protein associated with Alzheimer,s, in the brain, ... reported today at the Alzheimer,s Association International Conference ... of the studies, the decreased ability to identify ...
Breaking Medicine News(10 mins):Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 2Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 4Health News:The Little Gym of Pearland, TX Now Under New Ownership and Management 2Health News:2014QuinceaneraDresses.com Releases Its New Quinceanera Dresses 2Health News:Fadhits.com Announces a Special Offer on Elegant Quinceanera Dresses 2Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7
... New findings show that treatment with a specific alpha ... for men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). ... relaxing the muscles in the bladder neck and prostate. ... States, the EU and Japan to treat painful symptoms ...
... 11 (HealthDay News) -- Some men with enlarged prostate ... severe complications as a result, according to a new ... for enlarged prostate, the rate of men operated on ... the rate of discharges for men for enlarged prostate ...
... NJIT and UMDNJ have executed a license agreement with The ... on which a patent is pending. The tonometer ... Gordon Thomas, PhD, and Robert Fechtner, MD, director of the ... was a member of the research team. "We ...
... address a major new risk for the global supply ... the supply chain as pharmaceutical companies increasingly outsource the ... topic of the cover story in the current edition ... C&EN Senior Editor Rick Mullin explains that ...
... first time, researchers at McMaster University have conclusive evidence ... and behaviour. The findings are important because several ... are frequently associated with anxiety or depression. In addition ... as late onset autism, may be associated with an ...
... new study led by the University of Leicester has concluded ... in a doctor,s surgery helps to reduce emergency hospital admissions. ... Sciences at the University of Leicester revealed a correlation between ... hospital admissions. The research, published in Emergency Medical ...
Cached Medicine News:Health News:Experimental treatment offers relief from painful prostate condition 2Health News:Fewer Men Having Surgery to Treat Enlarged Prostate: Study 2Health News:NJIT and UMDNJ license personal tonometer technology for innovative glaucoma testing 2Health News:That anxiety may be in your gut, not in your head 2Health News:Patients who see preferred doctor less likely to go for emergency hospital admission 2
For the qualitative and semi-quantitative measurement of RF in human serum....
... The Newmarket Laboratories RPR kits use ... of lipid antigens, which will combine ... or plasma. The particles are suspended ... eliminate non - specific reactions. Positive ...
Rapid Plasma Reagin (RPR) set is a non-treponemal flocculation test that is,used for the qualitative and semi-quantitative determination of reagin,antibodies in serum or plasma from persons with syph...
... For use as a quality ... IgG antibody to Toxoplasma gondii ... rubella virus (rubella IgG), IgG ... and IgG antibody to herpes ...
Medicine Products: