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

0

GOOD

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:5/24/2013)... , May 24, 2013 The ... for systemic delivery of therapeutic agents has been receiving ... drug delivery showing significant promise. The crucial formulation considerations ... delivery device play a major role in the efficiency ... in the development of new formulation techniques and devices ...
(Date:5/24/2013)... England and BOSTON , May 24, ... discovery and development company, is pleased to announce that it has ... to augment the Company,s business development capabilities in Japan ... more than 15 years of experience in business development, licensing and ... Sciences, Inc., Roche Pharma ( Japan ), Nippon Roche ...
(Date:5/23/2013)... , May 24, 2013 3SBio Inc. ... "Company"), a leading China -based ... marketing biopharmaceutical products, announced today that, at an ... Company,s shareholders voted in favor of the proposal ... and plan of merger dated February 8, 2013, ...
Breaking Medicine Technology:Inhalaltion Drug Delivery: 11-12 September - Berlin, Germany 2Heptares Augments Business Development Capabilities in Japan and Other Asian Territories 23SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement 23SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement 3
(Date:5/24/2013)... have today released updated guidelines on Hormone Replacement Therapy ... the benefits and the risks. The new guidelines appear ... published by SAGE. , Over the last 11 ... of youth" to being considered extremely risky and only ... of the Women,s Health Initiative (WHI) trial in 2002, ...
(Date:5/24/2013)... May 24, 2013 Today marks the ... online Itinerary Builder. , The redesigned and enhanced ... unique vacation itineraries on their computer or mobile device ... The interactive tool allows users to fill in their ... through and select their choice of vacation packages, accommodations, ...
(Date:5/24/2013)... (PRWEB) May 24, 2013 DiaperBuys.com is ... Baby Photo Contest. Lindsey Willis of Olathe, Kansas, won ... from DiaperBuys. Second prize was a three-month supply ... North Las Vegas, Nev.; and third prize, a one-month ... The contest was run through the company’s Facebook page. ...
(Date:5/24/2013)... 2013 Wednesday, 15th May 2013 | 10am ... to access webinar playback: http://bit.ly/10Rt0ZH , Ongoing regulatory ... markets. Across the globe and particularly in Europe, a number ... M&A activity . For dealmakers, understanding how the likes of ... Tax’ affects your corner of the market will give you ...
(Date:5/24/2013)... 24, 2013 http://www.resource4thepeople.com/defectivedrugs/Zithromax-lawsuits.html ... latest update involving allegations that the use of ... can allegedly cause potentially fatal irregular heart ... May 17, 2013* that Health Canada has joined ... that Zithromax can cause abnormal changes in the ...
Breaking Medicine News(10 mins):Health News:Create and Win the Perfect Halifax Getaway with the All-New Itinerary Builder 2Health News:DiaperBuys.com Announces Photo Contest Winners 2Health News:Register to Access Webinar Playback - The Impact of Financial Regulation on M&A in 2013 2Health News:Register to Access Webinar Playback - The Impact of Financial Regulation on M&A in 2013 3Health News:2013 Alleged Zithromax Arrhythmia and Sudden Death Cases Update: Canadian Health Officials Issue Warning 2Health News:2013 Alleged Zithromax Arrhythmia and Sudden Death Cases Update: Canadian Health Officials Issue Warning 3Health News:2013 Alleged Zithromax Arrhythmia and Sudden Death Cases Update: Canadian Health Officials Issue Warning 4
... now choose a gender of their liking and some can ... procedure developed at the All India Institute of Medical Sciences ... already given proper gender identities as males or females and ... the premier research and referral institute said. ,"Treatment ...
... now looking at lactate with a much more positive ... brain in the immediate //hours after a traumatic brain ... are right, it could change how emergency room physicians ... in the first critical hours after injury. ...
... screen all 20,000-plus human genes for biological activity, scientists have ... cancer cells are to certain chemotherapy drugs.// ,In ... edition of the journal Nature, researchers at UT Southwestern Medical ... molecules – the first used by a university research center ...
... in full bloom, the American Academy of Otolaryngology – Head ... can do to cope with the pollen in the air, ... // ,This spring, pollen from blooming trees and plants ... causing itching eyes, sneezing, nasal stuffiness, nasal congestion and drainage, ...
... may result in erectile dysfunction, decreased libido, anemia, sarcopenia, ... ,While a low serum testosterone level is ... hypogonadism on overall physical functioning and fall risk has ... 23 issue of the Archives of Internal Medicine, Orwoll ...
... than one-third of Queensland men have never been screened for ... ,Screening for colorectal cancer currently has stronger scientific ... prostate or skin cancer, but a new study in the ... undergo the colorectal cancer test than the other two. ...
Cached Medicine News:Health News:New Procedure Paves Way for Eunuchs to Choose a Gender and Conceive 2Health News:Study Challenges Conventional Treatment of Traumatic Brain Injury 2Health News:Gene Screening Points Way to More Effective Chemotherapy 2Health News:April Showers Bring May Flowers – And Plenty of Pollen, To 2Health News:Low Serum Testosterone Levels Associated With Fall Risk in Elderly Men 2
... Rochester Medical's line of ... intermittent catheters you would ... four product configurations - ... antibacterial hydro - are ...
The latex-free, PVC-free Antibacterial Hydro Personal catheter combines two remarkable innovations into one exclusive catheter that delivers an antibacterial agent while providing the virtually frict...
The Antibacterial Personal Catheter® features a unique silicone composition that provides an antibacterial coated soft outer layer of silicone combined with a firm inner layer....
... Rochester Medical's line ... the intermittent catheters you ... All four product configurations ... and antibacterial hydro - ...
Medicine Products: