Navigation Links
FDA Approves First Drug to Prevent Premature Births
Date:2/7/2011

those women."

Hydroxyprogesterone caproate has not been without some controversy. In 2006, an FDA advisory committee considering hydroxyprogesterone caproate to treat preterm birth brought up safety concerns, including a possible association with second trimester miscarriages.

Hydroxyprogesterone caproate is also the same drug as a much older one called Delalutin, which was approved by the FDA in 1956 and was used to treat female hormone disturbances and cancer, but withdrawn from the market for business reasons in 2008, the agency says.

"Makena is chemically the same as Delalutin," Burgess said.

What is new here is that a drug company will be making the drug; it won't have to be made up in pharmacies, according to Fleischman. "There will be consistency and high quality. This makes it a breakthrough not only that it's FDA approved and doctors will be comfortable in recommending it, but also there will be high quality and consistency for women as they take it," he said.

Dr. Gene Burkett, a professor of obstetrics and gynecology at the University of Miami Miller School of Medicine said that "this is something we have been using with women prone to preterm labor. It has been almost a standard of care for the last five or six years."

"Makena was approved under FDA's accelerated approval regulations, which allow promising drugs to be approved based on showing a benefit on a 'surrogate endpoint' that is likely to predict an actual clinical benefit," Burgess said. In this case, it was reducing the risk of delivery before 37 weeks.

Part of the terms of this approval require the manufacturer to conduct studies that demonstrate that the drug has a clinical benefit, she said.

In making its decision, the FDA reviewed data on the safety and effectiveness of Makena from a clinical trial that included 463 pregnant women who had a history of a spontaneous preterm birth.

Among those receiving Makena, 37 percent delivered be
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Swiss agency approves clinical trial of UCI-created neural stem cell therapy
2. ACGME board approves final duty hour and supervision standards for resident education
3. FDA Approves 1st Oral Drug to Reduce MS Relapses
4. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
5. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
6. FDA approves first human neural stem cell clinical trial to treat brain tumors
7. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
8. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
9. House of Representatives Approves Health-Care Reform Bill
10. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
11. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves First Drug to Prevent Premature Births 
(Date:8/3/2015)... ... August 03, 2015 , ... It’s 25 miles ... Springs, California’s northernmost and among its least visited State Parks. The volcanic area ... main outflow is at Ahjumawi Lava Springs, part of the Fall River Springs ...
(Date:8/3/2015)... Illinois (PRWEB) , ... August 03, 2015 , ... Illinois ... NA) effective July 31. , The acquisition includes all of IBAM NA’s cyclotron ... opportunity to have both, a robust regionally located business, as well as a large ...
(Date:8/3/2015)... Silver Spring, MD (PRWEB) , ... August 03, 2015 , ... ... announce the addition of a new associate podiatrist, creating the largest medical practice in ... in foot and ankle medicine. FASMA operates 21 locations with 33 doctors. , Dr. ...
(Date:8/2/2015)... ... August 03, 2015 , ... Career Step, an online ... the Association for Healthcare Documentation Integrity’s (AHDI) conference being held in Alexandria, Virginia, ... opportunity the AHDI conference provides us to interact with those in the healthcare ...
(Date:8/1/2015)... In (PRWEB) , ... August 02, 2015 , ... ... month which will help the continuity of care for patients at this natural health ... of the unknown," Clinic Director Mary Heal said. "Heather's role is vital to our ...
Breaking Medicine News(10 mins):Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 2Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 3Health News:Medicine Lake Aquifer could ease California drought says fresh water advocate Sharon Kleyne – but is this necessary? 4Health News:Illinois Health & Science Expands Nuclear Medicine Footprint With Purchase of IBA Molecular North America, Inc. 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 3Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 4Health News:Career Step to Exhibit at AHDI Conference in Alexandria, Virginia on August 7-8 2Health News:New Patient Advocate Enhances Natural Health Care 2
... Prenatal Solution Key Factor in Decision for ... Jan. 8 Allscripts announced today that ... multi-specialty group practices in the Southeast United ... Health Record (EHR) to automate and connect ...
... Hospital have demonstrated a more effective treatment for ... antibiotics clindamycin and azithromycin, which kill bacteria by ... a standard first-line treatment with the "beta-lactam" antibiotic ... burst. , The finding is important ...
... 8 Allscripts-Misys Healthcare,Solutions, Inc., formerly Allscripts Healthcare ... financial results for the three and six,months ended ... (Logo: http://www.newscom.com/cgi-bin/prnh/20061005/ALLSCRIPTSLOGO-b ) , ... six months ended November 30, 2008,include results from ...
... 8 /PRNewswire-Asia/ -- Chindex International, Inc.,(Nasdaq: CHDX ... of Western healthcare products and services in the People,s ... the 2009 UBS Greater,China Conference, to be held in ... The 2009 UBS Greater China Conference will ...
... should be used when assessing traditional risk factors, experts say ... -- or "biomarkers" -- of inflammation may provide useful information ... research says. , "If you are very high or very ... said study lead author Dr. Vijay Nambi, a cardiologist at ...
... business continues to drive overall performanceDALLAS, Jan. 8 ... leader in hosted services for email encryption and e-prescribing, ... officer, Rick Spurr."We ended the year on a high ... the highest orders for the year in the fourth ...
Cached Medicine News:Health News:Physician Associates, LLC Selects Allscripts Electronic Health Record to Connect and Automate 80 Physicians 2Health News:Physician Associates, LLC Selects Allscripts Electronic Health Record to Connect and Automate 80 Physicians 3Health News:Physician Associates, LLC Selects Allscripts Electronic Health Record to Connect and Automate 80 Physicians 4Health News:Study finds more effective treatment for pneumonia following influenza 2Health News:Study finds more effective treatment for pneumonia following influenza 3Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 2Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 3Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 4Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 5Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 6Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 7Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 8Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 9Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 10Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 11Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 12Health News:Allscripts Reports Fiscal 2009 Second Quarter Results 13Health News:Chindex International Inc. Announces Participation in the 2009 UBS Greater China Conference 2Health News:Inflammation Markers May Help Predict Stroke Risk 2Health News:Inflammation Markers May Help Predict Stroke Risk 3Health News:Zix Corporation CEO Provides Corporate Update for Q4 and Year-End 2008 2Health News:Zix Corporation CEO Provides Corporate Update for Q4 and Year-End 2008 3Health News:Zix Corporation CEO Provides Corporate Update for Q4 and Year-End 2008 4
(Date:8/2/2015)... , Aug. 3, 2015  Lexicon Pharmaceuticals, Inc. ... pivotal TELESTAR Phase 3 clinical trial met its ... etiprate in treating cancer patients with carcinoid syndrome ... standard of care. Telotristat etiprate was discovered using ... and is the company,s first discovery to complete ...
(Date:7/31/2015)... , July 31, 2015  Seeger Weiss LLP is ... (FDA) issued a warning letter to C.R. Bard, the manufacturer ... taking adequate strides to correct violations the agency found at ... these violations after the FDA cited them during Inspectional Observations ... in Bard,s Tempe, AZ , location and ...
(Date:7/31/2015)... July 31, 2015 RnRMarketResearch.com ... market research report that provides an overview of ... data sourced from in-house databases, secondary and primary ... needles market products pipeline spread across 124 pages, ... 73 tables and 5 figures is now available ...
Breaking Medicine Technology:Lexicon Pharmaceuticals Reports Positive Top-Line Results For Pivotal Phase 3 Telotristat Etiprate Study In Cancer Patients With Carcinoid Syndrome 2Lexicon Pharmaceuticals Reports Positive Top-Line Results For Pivotal Phase 3 Telotristat Etiprate Study In Cancer Patients With Carcinoid Syndrome 3Lexicon Pharmaceuticals Reports Positive Top-Line Results For Pivotal Phase 3 Telotristat Etiprate Study In Cancer Patients With Carcinoid Syndrome 4Lexicon Pharmaceuticals Reports Positive Top-Line Results For Pivotal Phase 3 Telotristat Etiprate Study In Cancer Patients With Carcinoid Syndrome 5Lexicon Pharmaceuticals Reports Positive Top-Line Results For Pivotal Phase 3 Telotristat Etiprate Study In Cancer Patients With Carcinoid Syndrome 6Seeger Weiss LLP Reports That The FDA Has Issued A Warning Letter To IVC Filter Manufacturer, C.R. Bard 2Seeger Weiss LLP Reports That The FDA Has Issued A Warning Letter To IVC Filter Manufacturer, C.R. Bard 3Syringes and Needles Market Products Pipeline Review 2015 Report 2Syringes and Needles Market Products Pipeline Review 2015 Report 3Syringes and Needles Market Products Pipeline Review 2015 Report 4Syringes and Needles Market Products Pipeline Review 2015 Report 5
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: