Navigation Links
FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes
Date:10/29/2008

BRIDGEWATER, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra(R) (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4 years and older) with diabetes mellitus.

The approval of Apidra(R) for pediatric use is based upon FDA review of a 26-week, phase III, open-label, active control study of Apidra(R) in comparison with insulin lispro, in 572 children and adolescents (4 years and older) with type 1 diabetes.

"Sanofi-aventis is committed to providing children with diabetes, as well as their families and healthcare providers, with safe and effective treatment options to help address the challenges associated with the condition and to help decrease the long-term risk for devastating complications of diabetes," said Michelle Baron, MD, vice president, Metabolism Medical Unit, sanofi-aventis U.S. "We are pleased that the fast onset of action and mealtime dosing flexibility of Apidra(R) will now be available to children 4 years and older."

Apidra(R) has a rapid onset and short duration of action and should normally be used in combination with a longer-acting or basal insulin. Apidra(R) can also be used in insulin infusion pump therapy for blood sugar control.

About the Study

The approval of Apidra(R) for pediatric use is based upon a 26-week, phase III, open-label, active control study of Apidra(R) in comparison with insulin lispro in 572 children and adolescents (4 - 17 years of age) with type 1 diabetes. Study patients received insulin glulisine or lispro 0-15 minutes premeal. These patients received concomitant treatment with insulin glargine once daily or NPH twice daily as basal insulin. The majority of the patients received insulin glargine as part of their basal-prandial regimen (69.7% and 72% in the Apidra(R) and insulin lispro treated groups, respectively).

The study compared the efficacy of Apidra(R
'/>"/>

SOURCE Sanofi-aventis
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 11, 2014 Patient engagement has become ... organizations are turning to an assortment of marketing ... part of this evolving approach to patient engagement, ... and engage patients throughout their experiences with a ... By mapping the patient journey and employing a ...
(Date:7/11/2014)... , July 11, 2014 Research and ... "Global and Chinese Medical X-ray Film Industry Report 2014" ... http://photos.prnewswire.com/prnh/20130307/600769 Global And Chinese Medical ... in-depth study on the current state of the Global ... Chinese situation. The report provides a basic overview ...
(Date:7/11/2014)... 2014  Kindred Hospital Houston Northwest, with Wound ... of its new outpatient wound healing center.  The ... with chronic, hard to heal wounds. Chronic wounds ... amputation, lower leg wounds related to blood flow ... traumatic injury wounds which are complex and demonstrate ...
Breaking Medicine Technology:New Study Uses Six-Step Patient Journey as Framework for Consumer-Focused Marketing Opportunities 2Global and Chinese Medical X-ray Film Industry Report 2014 2Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2
... Mass. , Feb. 4 Recognizing that corporate ... they contain, Northern Light ( www.northernlight.com ) today announced that ... excess of $2 billion can be searched, analyzed ... been steadily increasing the number of market research sources integrated ...
... N.C. , Feb. 4 Gorbec Pharmaceutical ... prescription pharmaceutical products, is opening a GMP-compliant analytical laboratory ... expand Gorbec,s current services for analytical method development and ... its U.S. customer base as well as develop a ...
Cached Medicine Technology:Northern Light Surpasses $2 Billion Worth of Research Content Integrated Into SinglePoint Strategic Research Portals 2Northern Light Surpasses $2 Billion Worth of Research Content Integrated Into SinglePoint Strategic Research Portals 3Gorbec Pharmaceutical Services, Inc. Announces the Launch of Its GMP Analytical Laboratory in China 2
(Date:7/13/2014)... 2014 A Xarelto lawsuit webpage ... to provide consumers with the most current information regarding ... the blood-thinning medication, as well as the growing ... around the country. The law firm is now offering ... from life-threatening internal bleeding and related complications while using ...
(Date:7/13/2014)... July 13, 2014 According to The ... is a comprehensive program that teaches people how to ... neuropathy without medications. This program also provides people ... of peripheral neuropathy , including numbness, prickling, burning, and ... review that this home treatment program can help people ...
(Date:7/12/2014)... Recently, iFitDress.com, one of the world’s leading ... red evening gowns . What’s more, all these hot outfits ... The company’s senior spokesman states, “We are proud to announce ... is an enjoyable shopping experience. In addition to the big ... low prices do not always mean bad quality. All the ...
(Date:7/12/2014)... The report, "Phthalic Anhydride and Derivatives ... Application & Geography – Trends & Forecast to 2018," ... forecasting of market volume and value. The report also ... The market of phthalic anhydride is projected to grow ... million by 2018, with a CAGR of 5.24% from ...
(Date:7/12/2014)... The Security Analytics market is estimated to grow from ... at an expected CAGR of 9.7% for the period ... increasing number of security breaches, continued line of sophisticated ... organizations are enormous. Vendors in the security analytics market ... develop better and more secure systems. , There has ...
Breaking Medicine News(10 mins):Health News:Xeralto Lawsuit Page Launched By Wright & Schulte LLC To Provide Information On Potential For Xarelto Bleeding Side Effects, Growing Litigation 2Health News:Xeralto Lawsuit Page Launched By Wright & Schulte LLC To Provide Information On Potential For Xarelto Bleeding Side Effects, Growing Litigation 3Health News:Xeralto Lawsuit Page Launched By Wright & Schulte LLC To Provide Information On Potential For Xarelto Bleeding Side Effects, Growing Litigation 4Health News:The Peripheral Neuropathy Program Review Exposes Randall Labrum's Peripheral Neuropathy Treatment Program – Vkool.com 2Health News:The Peripheral Neuropathy Program Review Exposes Randall Labrum's Peripheral Neuropathy Treatment Program – Vkool.com 3Health News:Discounted Red Evening Gown Announced by iFitDress.com 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 4Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 4
... ,better for you, options; portion-controlled treats remain popular this ... ... Oct. 1 For the 93 percent of kids who will,trick-or-treat ... ever before, including more health-minded product options,available alongside the classic treats, ...
... ZURICH, Switzerland, October 1 , - Share Exchange Offer to ... & Johnson - ISIN: US4781601046 - Symbol: JNJ, The K&N ... every 1 Johnson & Johnson share a change into 1 share ... The offer period starts on 13th October 2008 and ends ...
... of almost 1,500 kidney cancer patients treated at Memorial ... as much kidney tissue as possible may improve overall ... at the time their cancer is diagnosed. The finding ... function appear to be increasing. , "In patients who ...
... is a fact that,Multi-Drug Resistant organisms are on ... medicines. According to the World Health Organization,(WHO) these ... and mortality rates, which has led to a ... safe, natural and,complementary solutions to this growing problem., ...
... says physicians have unique opportunity to help parents and ... ... Washington, DC (Vocus) October 1, 2008 ... their families understand the http://www.childrensnational.org/?utm_source=pressrelease&utm_medium=9_30&utm_campaign=driving_safety [importance of responsible driving], ...
... on the horizon, dentists, ,as well as all other medical practitioners, ... Flasch, of Flasch Business Expansion. An award winning consultant with over ... expand their practices using precise business strategies. , ... ...
Cached Medicine News:Health News:Latest Trick-or-Treats Give You Something Good to Eat 2Health News:Latest Trick-or-Treats Give You Something Good to Eat 3Health News:Latest Trick-or-Treats Give You Something Good to Eat 4Health News:Research suggests doctors should consider kidney-sparing surgery 2Health News:Research suggests doctors should consider kidney-sparing surgery 3Health News:Argentyn 23(R) Homeopathic First Aid Gel - Another World's First by Natural-Immunogenics Corp. for Healthcare Professionals 2Health News:Healthcare Providers Can Help Reduce Teen Driving Deaths 2Health News:Healthcare Providers Can Help Reduce Teen Driving Deaths 3Health News:Medical Marketing Expert Offers Dentists Tips for Thriving Down Economy After the Wall Street Dilemma 2Health News:Medical Marketing Expert Offers Dentists Tips for Thriving Down Economy After the Wall Street Dilemma 3
With MediLive MindStream you can make, cut and edit digital videos, add commentaries and notes, and save them. MediLive MindStream - intuitive user interface and high-resolution monitor all in one....
... The VISUPAC system and the FF 450plus ... a unique level of accuracy and security ... or aftermarket configuration. Without this level of ... be assured.,Matching the VISUPAC system pixel for ...
... Monitor is the smartest, toughest and most ... an on-board artificial intelligence algorithm, DiogenesTM, the ... arrhythmias while on the patient. The Decipher ... all the rigorous tests required to monitor ...
... The Epicardia 4000 is a hospital-grade ... Epicardia software, Diogenes Arrhythmia and ST analysis ... supporting hardware and software. Facilities with an ... over running reports, customizing them to suit ...
Medicine Products: