Navigation Links
Takeda Responds to FDA Advisory Committee Recommendation
Date:7/14/2010

nd other public health matters. The FDA frequently convenes its panel of outside experts to provide guidance and recommendations; however, the recommendations of the committee are not a final decision. The FDA will evaluate the committee's decision and their final recommendations will follow.

Takeda remains committed to ACTOS and to the millions of people living with type 2 diabetes. Takeda is the inventor and developer of ACTOS, which was launched commercially in the U.S. in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Since its launch, more than 100 million ACTOS family prescriptions have been written, covering more than 10 million patients. In clinical trials using ACTOS in monotherapy, the most common adverse events (greater than or equal to 5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus, and pharyngitis.

About ACTOS® (pioglitazone HCl) Indications and Usage

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS has been studied as a monotherapy and in combination with sulfonylurea, metformin, or insulin.

Important Safety Information

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.

ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

ACTOS may cause low blood sugar when taken in combination with insulin
'/>"/>

SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
2. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
3. 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
4. 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
5. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
6. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
7. Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filings in Europe
8. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
9. Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)
10. Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes
11. 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
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... PLAINFIELD, N.J. , July 24, 2014  PTC ... that the Company will host a webcast conference call ... provide an update on the company,s business and outlook ... before the opening of the market. ... (domestic) or (973) 935-8152 (international) five minutes prior to ...
(Date:7/24/2014)... 2014  Uroplasty, Inc. (NASDAQ: UPI ), ... markets innovative proprietary products to treat voiding dysfunctions, ... first quarter ended June 30, 2014.  Global ... System grew 19% to $4.1 million, as compared ... the prior year.  Total revenue for the fiscal ...
(Date:7/24/2014)... Calif. , July 24, 2014 Amgen (NASDAQ: ... its second quarter financial results on Tuesday, July 29, 2014, ... will be followed by a conference call with the investment ... Amgen will be Robert A. Bradway , chairman and ... team. Live audio of the conference call will ...
Breaking Medicine Technology:Uroplasty Reports Fiscal First Quarter Results 2Uroplasty Reports Fiscal First Quarter Results 3Uroplasty Reports Fiscal First Quarter Results 4Uroplasty Reports Fiscal First Quarter Results 5Uroplasty Reports Fiscal First Quarter Results 6Uroplasty Reports Fiscal First Quarter Results 7Uroplasty Reports Fiscal First Quarter Results 8Uroplasty Reports Fiscal First Quarter Results 9Uroplasty Reports Fiscal First Quarter Results 10Uroplasty Reports Fiscal First Quarter Results 11Amgen Announces Webcast of 2014 Second Quarter Financial Results 2
(Date:7/26/2014)... July 26, 2014 Recently, iFitDress.com, a ... for women, has unveiled its new range of high ... offer on the brand new items; they are now ... , iFitDress.com is one of the leading suppliers ... officer, all the wholesale party dresses have ...
(Date:7/26/2014)... Dallas,Texas (PRWEB) July 26, 2014 “BRIC ... on the BRIC Sinuscopes market. The report provides value, ... average prices (in US dollars) within market segments – ... shares and distribution shares data for each of these ... market participants, pipeline products, and news and deals related ...
(Date:7/26/2014)... TX (PRWEB) July 26, 2014 ... or encephalomyelitis disseminata, is an inflammatory disease in ... the brain and spinal cord are damaged. This ... nervous system to communicate, resulting in a wide ... and sometimes psychiatric problems. Multiple sclerosis takes several ...
(Date:7/26/2014)... Seattle, Wa (PRWEB) July 26, 2014 ... updated by Vkool.com, this is a comprehensive bodybuilding program ... simultaneously without using anabolic steroids . The program ... lean muscle without cardio. , Vkool reveals in ... exercises and workouts that can help men get ripped ...
(Date:7/25/2014)... Dental Perfection, a Derby cosmetic dentist ... general dentistry, clear braces and much more, has just ... in Derby. The new practice, which is scheduled to ... in Littleover, Derby. Patients may already pre-register for the ... dental practice, which is headed by Invisalign specialist and ...
Breaking Medicine News(10 mins):Health News:High Quality Wholesale Party Dresses Online at iFitDress.com 2Health News:Sinuscopes Market in BRIC (Brazil, Russia, India & China) Forecast to 2020 Report Available at MarketOptimizer.org 2Health News:Sinuscopes Market in BRIC (Brazil, Russia, India & China) Forecast to 2020 Report Available at MarketOptimizer.org 3Health News:Sinuscopes Market in BRIC (Brazil, Russia, India & China) Forecast to 2020 Report Available at MarketOptimizer.org 4Health News:Multiple Sclerosis Therapeutics Clinical Trials Market Review H2 2014 Analysis Report Available at MarketOptimizer.org 2Health News:Multiple Sclerosis Therapeutics Clinical Trials Market Review H2 2014 Analysis Report Available at MarketOptimizer.org 3Health News:Multiple Sclerosis Therapeutics Clinical Trials Market Review H2 2014 Analysis Report Available at MarketOptimizer.org 4Health News:Metabolic Enhancement Training Review Exposes Scott Abel's Program for Bodybuilding – Vkool.com 2Health News:Metabolic Enhancement Training Review Exposes Scott Abel's Program for Bodybuilding – Vkool.com 3Health News:Derby Cosmetic Dentist Dental Perfection to Open New Practice in Littleover, Derby this September 2
... in small study took capsules equivalent to brewed beverage, , ... green tea might slow the progression of prostate cancer, the ... 26 men, 41 to 72 years old, who had prostate ... took four capsules a day of an investigational agent called ...
... , Local Vascular Surgeon Named National Principal Investigator , ... from Arizona Heart Institute performed the first procedure in ... Vascutek Anaconda Stent Graft System , an investigational, minimally ... , Leading the study efforts in the U.S. ...
... , DEERFIELD BEACH, Fla., June 19 Sentry Data ... scanning device, Sentinel Mobile Manager(TM), as part of ... feedback and the desire to provide increased value ... with Sentinel RCM,s(TM) core functionality and provides a ...
... BEIJING, June 19 /PRNewswire-Asia-FirstCall/ -- China ... a leading China-based medical device,company that develops, manufactures and ... financial results for,the fourth fiscal quarter (,4Q FY2008,) and ... 2009 (,FY2008,). The Company,s 2008 fiscal year ends ...
... ... readers, AmericanHealthandBeauty.com has added Dysport, formerly known as Reloxin, as a procedure on their website. ... Houston, TX (PRWEB) June ... lines and wrinkles on the face, has recently gained FDA approval and is expected to ...
... (NYSE: SRZ ) today announced that it will transition ... As previously disclosed in its 2008 10-K, Sunrise could be terminated ... to comply with their financial covenants in 2008. HCP announced ... , "While we regret the loss of these communities, it ...
Cached Medicine News:Health News:Green Tea Component May Slow Prostate Cancer 2Health News:Arizona Heart Institute Enrolls First Patient in Anaconda(TM) Investigational Study for the Treatment of Abdominal Aortic Aneurysm 2Health News:Arizona Heart Institute Enrolls First Patient in Anaconda(TM) Investigational Study for the Treatment of Abdominal Aortic Aneurysm 3Health News:Sentry Data Systems, Inc. Announces: Sentinel RCM(TM) - Now with Mobile Manager(TM) Included! 2Health News:China Medical Technologies Announces Selected Unaudited Preliminary Financial Results for the Fourth Fiscal Quarter and Full Year Ended March 31, 2009 2Health News:China Medical Technologies Announces Selected Unaudited Preliminary Financial Results for the Fourth Fiscal Quarter and Full Year Ended March 31, 2009 3Health News:Dysport Added as a Procedure on AmericanHealthandBeauty.com: Let the Wrinkle Wars Begin 2Health News:Dysport Added as a Procedure on AmericanHealthandBeauty.com: Let the Wrinkle Wars Begin 3
... Tissue transglutaminase (tTg) is a ... of proteins. Tissue transglutaminase is also ... by the endomysial antibody immunofluorescence (EMA) ... 29060). Anti-tTg IgA and IgG serologic ...
... training it needs with the NetLearning Management ... Capital Management System in one. Whether it ... and HIPAA, understanding compliance reporting for OSHA, ... through continuing education courses, the NetLearning system ...
We offer small and large pre-gelled Surface Electrodes suitable for EMG or EGG recordings....
We offer small and large pre-gelled Surface Electrodes suitable for EGG or EMG recordings. Surface Electrodes, Skin Preparation and Conductive Cream complete the setup for a EGG study and are essenti...
Medicine Products: