Navigation Links
FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
Date:2/4/2011

t with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37 percent delivered early (before 37 weeks) as compared with 55 percent of women in the control group.  

A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children ages 2.5 years to 5 years reached similar developmental targets, regardless of the mother's treatment.  The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018.  That study is expected to include 580-750 infants, depending on the number of study sites and mothers willing to participate.  

The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Consumers and health care professionals are encouraged to report adverse events from medications to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Makena is manufactured by Baxter Pharmaceutical Solutions LLC, based in Bloomington, Ind.

For more information:

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/UCM054420  

<
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

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:7/28/2014)... , July 28, 2014  ANI Pharmaceuticals, Inc. ... Company plans to release its second quarter and year-to-date ... the opening of the U.S. financial markets. The earnings ... section of the Company,s website, www.anipharmaceuticals.com . ... Executive Officer, and Charlotte C. Arnold , Vice ...
(Date:7/28/2014)... , July 28, 2014 PDL BioPharma, Inc. (PDL) ... will release its second quarter 2014 financial results for the ... after market close. PDL,s management will host a conference call ... discuss the financial results.  A slide presentation relating to the ... PDL website. Conference Call Details To access ...
(Date:7/28/2014)...  ProteinSimple announced today that it has launched a ... allows users to detect all proteins separated in the ... can analyze proteins without the need for an antibody.  ... analysis as we know it today. First, the Simple Western ... messy gels, no transfer tanks, no blots, no imaging ...
Breaking Medicine Technology:ANI Pharmaceuticals Schedules Conference Call for Second Quarter 2014 Financial Results 2PDL BioPharma to Announce Second Quarter 2014 Financial Results on August 11, 2014 2ProteinSimple Says "Never Run a Gel Again!" 2
(Date:7/28/2014)... University School of Medicine (BUSM) report variants in a ... developing Alzheimer,s disease (AD). The discovery of this novel ... that target PLXNA4 specifically. These findings appear in the ... most frequent age-related dementia affecting 5.4 million Americans including ... more than 40 percent of people age 85 and ...
(Date:7/28/2014)... The Wireline Services Market in Europe report defines and ... forecast of revenue. The Wireline services market in Europe is ... $2.4 billion by 2019, at a CAGR of 11.2%, for ... Wireline Services Market in Europe report, to get an idea ... of the segmentation in the European Wireline Services market, and ...
(Date:7/28/2014)... 28, 2014 (HealthDay News) -- A common inflammatory ... older people may increase the risk for heart ... A British study found that patients with polymyalgia ... -- conditions that affect the blood vessels. Doctors ... patients with polymyalgia rheumatica to reduce their risk ...
(Date:7/28/2014)... July 28, 2014A two-step decision tree analysis, incorporating ... and distill the many available quality standards, guidelines, ... national and international quality standards for radiation therapy, ... 2014 issue of Practical Radiation Oncology ... American Society for Radiation Oncology (ASTRO). , Guidelines, ...
(Date:7/28/2014)... Mediaplanet announced distribution of its third ... campaign that aims to raise awareness about the benefits ... TEALUX , a premium loose leaf tea shop ... readers with educational insight about the accessibility and growth ... forward and make conscious organic choices an option for ...
Breaking Medicine News(10 mins):Health News:Researchers identify potential biomarker for AD 2Health News:Europe Wireline Services Market is Expected to Reach $2.4 billion in 2019 - New Report by MicroMarket Monitor 2Health News:Europe Wireline Services Market is Expected to Reach $2.4 billion in 2019 - New Report by MicroMarket Monitor 3Health News:Europe Wireline Services Market is Expected to Reach $2.4 billion in 2019 - New Report by MicroMarket Monitor 4Health News:Inflammatory Muscle Disorder May Raise Risk for Heart Attack, Stroke 2Health News:Two-step decision tree analysis helps inform updates of RT best practices, quality standards 2Health News:Two-step decision tree analysis helps inform updates of RT best practices, quality standards 3Health News:Mediaplanet's "Organic Living" Campaign Raises Awareness About What Nature Invented, With the Help of Partner TEALUX 2
... Systems on the Role of Information Technology in Improving HealthcarePLANO, Texas, April 30 ... executive vice president and chief, ... Dr. Nathaniel Hupert, Director of The Preparedness Modeling Unit, ... Control and Prevention (CDC) and, ...
... their homes is the focus of Penn State,s portion ... that will also test the efficacy of a workplace ... "We,re seeing that stress in the workplace can create ... quality of life in families," says David Almeida, professor ...
... Practice LeaderNEW YORK, April 30 RSM McGladrey, ... a major expansion in the visibility of the ... York office. The expansion will be led by ... in the EBP sector.(Logo: http://www.newscom.com/cgi-bin/prnh/20080305/AQW023LOGO )"Companies ...
... Leaders and National Organizations Respond to Increasing Support ... DebateWASHINGTON, April 30 Men,s Health Network applauds ... today for introducing H.R. 2115, the "Men and ... would establish an Office of Men,s Health within ...
... the Newest Innovation in the Anthelios Franchise for UVA ... April 30 La Roche-Posay, the company that brought ... proudly announces the availability of Anthelios 60 Sunscreen(1) beginning ... brand,s new revolutionary sunscreen range offers ...
... WA April 30, 2009 Biogen Idec (NASDAQ: ... High-Risk AVONEX (interferon beta-1a) Multiple Sclerosis (MS) Prevention Study ... to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention ... granted approval for use in patients who experienced their ...
Cached Medicine News:Health News:Looking Forward: The Use of Health IT in Crisis 2Health News:Looking Forward: The Use of Health IT in Crisis 3Health News:Looking Forward: The Use of Health IT in Crisis 4Health News:Penn State plays integral role in $35 million stress project 2Health News:RSM McGladrey and McGladrey & Pullen LLP Announce Major Expansion of Employee Benefits Plan Practice in New York 2Health News:RSM McGladrey and McGladrey & Pullen LLP Announce Major Expansion of Employee Benefits Plan Practice in New York 3Health News:U.S. Representatives Hill and Murphy Introduce the 'Men and Families Health Care Act of 2009' 2Health News:Photos: ANTHELIOS 60 Sunscreen(1) with CELL-OX SHIELD(TM) Available May 1 Nationwide 2Health News:Photos: ANTHELIOS 60 Sunscreen(1) with CELL-OX SHIELD(TM) Available May 1 Nationwide 3Health News:First ten-year follow-up shows that treatment with AVONEX leads to long-term benefits in early multiple sclerosis patients 2
Triad Plus PVP-I Scrub Winged Sponges...
Prevail is a fast-acting, effective antimicrobial gel that makes preoperative preps easier. This unique gel formulation comes in a specifically designed, easy to use applicator for excellent flow con...
The applicator is designed for a smooth delivery of the solution for surgical procedures....
... Performance Panel consists of plasma specimens with ... for antibodies to the Hepatitis C Virus. ... manufacturers and diagnostic laboratories to evaluate their ... test systems are included for comparative analysis ...
Medicine Products: