Navigation Links
K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding 17-Alpha Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P
Date:10/13/2011

ST. LOUIS, Oct. 13, 2011 /PRNewswire/ -- K-V Pharmaceutical Company (the "Company") (NYSE: KV.A/KV.B) appreciates that the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal-Fetal Medicine (SMFM) have issued an information update that ensures healthcare providers, patients, and the payer community have the facts regarding FDA-approved Makena™.  The information update emphasizes that previous ACOG and SMFM statements regarding Makena were not intended to be used by private or public payers as a basis for interfering with the medical judgment of healthcare providers or denying patient access to Makena.  It also states that physicians should understand the inherent differences between an FDA-approved manufactured product and a compounded preparation, and that ACOG and SMFM's previous statements were not meant to suggest that Makena and compounded 17P are identical products.  

Healthcare providers understand that evidence-based medicine is the foundation of clinical practice.  Evidence from the NICHD MFMU Network study (Meis, et al.) supporting the use of hydroxyprogesterone caproate (17P) was based on drug manufactured under FDA's Good Manufacturing Practices (GMP) conditions, and not on drug made using compounding processes or obtained from compounding pharmacies.  The drug used in the NICHD study is available today as FDA-approved Makena.  

Access to FDA-approved Makena for clinically-indicated patients is an important public health priority.  Certain payer coverage policies have been influenced by a belief that unapproved compounded 17P formulations are the same as Makena.  These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena, consistent with their healthcare provider's medical judgment.  

As part of our commitment to patients, we have made substantial efforts to work with the payer com
'/>"/>

SOURCE K-V Pharmaceutical Company
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
7. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
8. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
9. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
10. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
11. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 2014 Research and Markets has announced ... Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023" ... of this report, the human microbiome market is segmented by ... market is expected to be valued as $294 million in ... 22.3% within the forecast period of 2019-2023. The market is ...
(Date:9/19/2014)... Sept. 19, 2014 UBM Medica US announces ... online community to help oncologists and other clinicians gain ... the use of targeted therapies and immunotherapies, discusses some ... treatment.  Every September, Blood Cancer ... raise awareness about blood cancers—helping to increase survival rates ...
(Date:9/19/2014)... Sept. 19, 2014  Alere Inc. (NYSE: ... the following statement today in support of President ... "As the global leader in rapid diagnostics for ... national strategy to address the serious threat of antibiotic ... the Administration on initiatives to promote the development of ...
Breaking Medicine Technology:Global Human Microbiome (Diabetes, Obesity, Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023 2Global Human Microbiome (Diabetes, Obesity, Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023 3OncoTherapy Network Highlights National Blood Cancer Awareness Month 2OncoTherapy Network Highlights National Blood Cancer Awareness Month 3OncoTherapy Network Highlights National Blood Cancer Awareness Month 4Alere Applauds President's Executive Order Combating Antibiotic-Resistant Bacteria 2
... LAIYANG, China , May 17 /PRNewswire-Asia-FirstCall/ -- ... pharmaceutical company with its principal operations in the People,s,Republic ... quarter,fiscal year 2010 ended March 31, 2010 . , ... -- Revenue was $25.6 million, a slight decrease of 0.6% ...
... Connecticut waterways may be safer from biomedical waste, thanks to ... CEDF, with loan-program partners, Connecticut ,s Department of Economic and Community and ... to a West Haven company that stems improper disposal of needles ... West Haven ...
Cached Medicine Technology:Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 2Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 3Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 4Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 5Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 6Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 7Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 8Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 9Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 10Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 11Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 12Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 13Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 14Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 15Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 16Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 17Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 18Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 19Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 20Jiangbo Pharmaceuticals Reports Results for Third Quarter of Fiscal Year 2010 21West Haven Firm Expands Biomedical Disposal Program with Community Economic Development Fund 2
(Date:9/19/2014)... -- Your brain structure could help predict how willing you ... Researchers at Yale University found those with greater volume in ... may be more likely to engage in risky behavior than ... study, funded by the U.S. National Institute on Aging, involved ... the Northeast. The researchers sought to determine how brain structure ...
(Date:9/19/2014)... By Alan Mozes ... (HealthDay News) -- Cancer patients burdened by stress and ... for complications following their operation, a new study suggests. ... "deficit" appeared to have a nearly three times greater ... or good quality of life. "We,ve long known ...
(Date:9/19/2014)... Cellular therapeutics using intact cells to treat and ... in medicine but it is hindered by the inability ... destination and persistence of these cells in patients without ... a paper published September 17 in the online journal ... University of California, San Diego School of Medicine, University ...
(Date:9/19/2014)... as frequently, and likely even more so, between ... a review of literature by Northwestern Medicine scientists. ... indicate that domestic violence affects 25 percent to ... However, a lack of representative data and underreporting ... true landscape, suggesting even higher rates. An estimated ...
(Date:9/19/2014)... September 20, 2014 As summer vacations end ... in Queens, NY now reminds area patients about the reality ... of our population affected by gum disease, there is simply ... For over 20 years Dr. Krishnan has treated patients with ... location. “Most patients that come in due to common symptoms ...
Breaking Medicine News(10 mins):Health News:Brain Structure Might Help Predict Risky Behavior 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 3Health News:A better way to track emerging cell therapies using MRIs 2Health News:Domestic violence likely more frequent for same-sex couples 2Health News:New York Periodontist Dr. Prabha Krishnan Now Raises Awareness about the Dangers of Untreated Decay, Gingivitis and Gum Disease During Self-Awareness Month 2Health News:New York Periodontist Dr. Prabha Krishnan Now Raises Awareness about the Dangers of Untreated Decay, Gingivitis and Gum Disease During Self-Awareness Month 3
... obesity, diabetes ... and heart disease, MINNEAPOLIS/ST. ... Minnesota,s Tucker Center for Research on Girls &,Women in Sport shows ... in physical activity outside of organized,sports is declining, especially as they ...
... Get ready to feel good. That,s the,mantra for ... feel good these days. The national March of Dimes ... a debut fundraiser called,"Stork Tunes." Just in time for ... will fund the nonprofit,s efforts to give every baby ...
... research,organization, announced that it has opened a new office ... Alexey V. Kornilov as,General Manager of its Russian operations., ... the leadership of Alexey,V. Kornilov, MD and will be ... Kornilov brings over 10 years of clinical,experience to Chiltern ...
... of SEIU Staff Bused in to Smash Into Meeting to ... Break ... The California Nurses,Association/National Nurses Organizing Committee tonight condemned a ... Employees,International Union who smashed into a conference of union members ...
... Cancer Institute researchers have found that a tumor protein ... related to a poor prognosis. , The presence ... referred to as GRB-7, in breast cancer tumors, is ... cancer, according to principal investigator Shiuh-Wen Luoh, M.D., Ph.D., ...
... among women with HER2 malignancies, study shows , , SUNDAY, ... significantly reduced the risk of recurrence for patients who ... , This type of breast cancer, representing about one-quarter ... forms of the disease. In this group, the vaccine ...
Cached Medicine News:Health News:Girls in Sports at Record High, Yet Many Girls Fail to Meet Minimal Standards of Physical Activity, University of Minnesota Report Says 2Health News:Girls in Sports at Record High, Yet Many Girls Fail to Meet Minimal Standards of Physical Activity, University of Minnesota Report Says 3Health News:Northwest Songwriter Dean Backholm Featured on National March of Dimes CD 2Health News:Chiltern Opens a New Office in Russia 2Health News:CNA/NNOC: RNs Condemn Violent Service Union Attack at Michigan Event 2Health News:CNA/NNOC: RNs Condemn Violent Service Union Attack at Michigan Event 3Health News:OHSU Cancer Institute researchers find connection between protein, prognosis in breast cancer 2Health News:Breast Cancer Vaccine Works Against Deadlier Form of Disease 2Health News:Breast Cancer Vaccine Works Against Deadlier Form of Disease 3
... The MICROM CTM 6 is a highly efficient ... and Cytology laboratories. The instrument is capable ... with continuous slide rack loading capabilities. The slide ... 30 slides each. User intuitive operation is made ...
... Miniaturized robotic system for spinal procedures. The ... a highly accurate, easy-to-use solution that enables ... and minimum intervention. SpineAssist currently answers a ... use guidance devices in pedicle screw insertion ...
... The SENSAR® Acrylic IOL with OptiEdge offers ... long-term refractive stability, and excellent handling. The ... had no reports of vacuoles; the patented ... reflections and provide 360 degrees of contact ...
ACRYSOF® Posterior Chamber Intraocular Lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in patients sixty years and older. These lenses are inten...
Medicine Products: