Navigation Links
Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)
Date:7/22/2009

DEERFIELD, Ill., July 22, and OSAKA, Japan, July 23 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification from the U.S. Food and Drug Administration (FDA) that the FDA extended the review of the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS((R)) (pioglitazone HCl). The new Prescription Drug User Fee Act (PDUFA) date for the FDC is September 4, 2009.

The NDA for the FDC of alogliptin and ACTOS was submitted in September 2008, following the NDA submission of alogliptin monotherapy in December 2007. On March 6, 2009 the FDA informed Takeda that based on the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA was not sufficient to meet certain statistical requirements outlined in that Guidance. On June 26, the FDA asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008 FDA Guidance for alogliptin.

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 diabetic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.

Important Safety Information About ACTOS

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

Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin.

If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Some patients have experienced visual changes while taking ACTOS.

Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.

Please visit the Takeda Pharmaceuticals North America, Inc. Web site at www.tpna.com for Complete Prescribing Information including the boxed warning about heart failure.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate Web site, www.takeda.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.


'/>"/>
SOURCE Takeda Pharmaceutical Company Limited
Copyright©2009 PR Newswire.
All rights reserved

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. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
10. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
11. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... FLINT, Mich. , Oct. 2, 2017 ... acquired 8th Day Software and Consulting, LLC , ... 8th Day Software, based in Tennessee ... Management LLC. 8th Day expands EnvoyHealth,s service offerings for ... product development. "In ...
(Date:10/2/2017)... Oct. 2, 2017  AllianceRx Walgreens Prime, the combined ... Walgreens and pharmacy benefit manager Prime Therapeutics LLC (Prime), ... which included the unveiling of new signage at its ... well as at a few other company-owned facilities across ... to patients, some of whom will begin to see ...
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... http://www.rebound-solution.com/ ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... As health professionals work to improve their approach ... patient is doing more than filling out a survey; in many cases health professionals ... emphasis in health care and research on the importance of active engagement with patients ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... Abilene, Texas (PRWEB) , ... October 13, 2017 , ... ... publication this week that explains one of the most popular and least understood books ... seems like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
Breaking Medicine News(10 mins):