Navigation Links
Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena® and Compounded 17P Formulations
Date:11/8/2011

track back specific product to specific manufacturing facilities, which is critically important should a problem with the medication arise.

Compounded 17P Formulations

  • 27 percent (8 of 30) of the compounded 17P vials tested failed to meet the USP standard for potency. The potency values of the compounded 17P vials ranged from just over half to a level more than 2.5 times the labeled potency. If these vials were administered to patients, some patients would not have received the dose of 17P that was reviewed and subsequently approved by FDA for safety and efficacy in this patient population. This variability in potency was comparable to those found in FDA's limited survey of compounded drug products conducted in 2006, which is available at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm204237.htm
  • 53 percent (16 of 30) of the vials of compounded 17P had levels of unknown impurities that exceeded at least one standard required by the FDA for Makena®. The potential toxic effects of these unidentified compounds in the intended patient population are unknown.  
  • Taken together, two-thirds (20 of 30) of the compounded 17P vials failed to meet at least one USP requirement (a standard used by some compounding pharmacies) or at least one FDA quality standard required of Makena® for potency and/or purity levels. Information was not obtained regarding the sterility of, or potential presence of endotoxins in, the compounded 17P vials.  
  • FDA-approved Makena® must meet FDA's quality standards before release for patient use.

About K-V Pharmaceutical Company

K-V Pharmaceutical Company is a specialty branded pharmaceutical company with a primary focus in the area of women's heal
'/>"/>

SOURCE Ther-Rx Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Adeona Appoints Jeff Lucero Riley as Independent Chairman
2. NCPA Digest Finds Independent Community Pharmacies Reducing Health Costs Through Generic Drug Use, Patient Counseling
3. Independent Radiology Assessment Panel Results Confirm Statistical Significance of Response and Progression Endpoints of Cell Therapeutics Pixantrone PIX301 Pivotal Trial
4. China Medicine Corporation Appoints PricewaterhouseCoopers As Independent Auditor To Audit Results For Fiscal Years 2006 - 2010
5. New Report: Independent Drugstores Thrive in Economic Recession
6. NeoStem Appoints Grant Thornton LLP as New Independent Registered Public Accounting Firm
7. Independent Expert Panel Calls for Information on Fragrance Ingredients Under Review
8. Nearly 7,000 Participate in Cardinal Healths Largest-Ever Annual Trade Show for Independent Pharmacies
9. As Economic Recovery Sputters, Independent Drugstores Shouldnt Shoulder Employers With Higher Costs
10. Independent Drugstore Lobbyists Try to Pad Profits at the Expense of Small Business
11. Florida Independent Drugstores Attack Mail-Service Pharmacies, Put Profits Ahead of Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... Africa , Jan. 23, 2015   Leatt Corporation ... personal protective equipment for all forms of sports, including ... Leatt-Brace® neck brace, announced today that the UISP Lega ... now requires all riders to wear a neck brace ...
(Date:1/23/2015)... and BOSTON , January 23, 2015 ... discovery and development company, is delighted to announce that the ... awarded to Miles Congreve (Vice President of Chemistry), ... Malcolm Weir (Chief Executive Officer and co-founder) for ...
(Date:1/22/2015)... UPI ), a medical device company that develops, ... dysfunctions, today reported financial results for the fiscal 2015 ... for the Company,s Urgent ®  PC Neuromodulation System grew ... as compared to $3.9 million in the third quarter ...
Breaking Medicine Technology:Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 2Leatt Announces Neck Braces Now Required For Motocross/Minicross Racing In Italy 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18
... diagnosed patients with a life-threatening type of leukemia to be featured ... - Exjade results at ASH to show benefits for ... key organs , , - New ... report on optimal post-surgery treatment strategy, Femara vs. tamoxifen , ...
... 3 The Leukemia & Lymphoma Society (LLS) and Memgen, LLC ... a cancer vaccine, at the University of California, San Diego ... LLS is collaborating on this trial in the hopes that it ... at treating patients with fludarabine refractory and/or 17p deleted chronic lymphocytic ...
Cached Medicine Technology:More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 2More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 3More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 4More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 5More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 6More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 7More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 8More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 9More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 10More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 11More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 12More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 13More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 14More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 15More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 16More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 17More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 18More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 19More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 20More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 21More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies 22The Leukemia & Lymphoma Society and Memgen Announce New Chronic Lymphocytic Leukemia Clinical Trial 2The Leukemia & Lymphoma Society and Memgen Announce New Chronic Lymphocytic Leukemia Clinical Trial 3
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has recently released ... website of AngelWeddingDress.com to find more details. , ... for a bridal party. AngelWeddingDress offers a variety of ... maternity wedding dresses are specially designed for 2015. , ...
(Date:1/22/2015)... January 22, 2015 Thousand of GranuFlo ... Care recalled its GranuFlo and NaturaLyte dialysis concentrates continue ... in U.S. District Court, District of Massachusetts, Bernstein Liebhard ... the Court has remanded a case filed by the ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved television host, ... 32nd Annual Miami Breast Cancer Conference planned and ... , shares that “a fast-growing, virulent” cancer in her ... not followed up her clean mammogram with an ultrasound. ...
(Date:1/22/2015)... IsoComforter, Inc. has introduced the most innovative and ... to treat specific body parts and muscle groups. , ... to use patented cold therapy machine with the innovative IsoTube ... muscle injuries. IsoComforter has become the industry leader in ...
(Date:1/22/2015)... 2015 As interest in the value of ... momentum worldwide, Rev. Eric J. Hall , president and ... (HCCN), will be the keynote speaker on January 27 at ... health system. , The conference, “Hope and Resilience: Innovative and ...
Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:IsoComforter Introduces Best of Class Cold Therapy Product to the Worldwide Market 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3
... rats finds that even one injection leads to dependent ... naturally occurring protein plays a role in the disrupted ... with drug and alcohol dependence, says a new study. ... changes in association with drug abuse, it could potentially ...
... May 28 (HealthDay News) --Should it worry you that there ... , Not especially, when you consider that there are 44 ... , This information comes to you from scientists at the ... same techniques that enabled them to map the human genetic ...
... Controlling Weight before PregnancyWHITE PLAINS, N.Y., May 28 ... right amount during pregnancy is critical to giving a ... Dimes said today in response to new guidelines from ... issued new guidelines for the amount of weight a ...
... Logistics (NGL), a premier provider of mission critical transportation, service/spare parts ... network of forward stocking locations (FSL,s). , ... Broomfield, ... provider of mission critical transportation, service/spare parts logistics , and ...
... Perot Systems, RCS advantages of increased cash flows and ... providersPLANO, Texas, May 28 Amerinet, a leading national ... PER ) ( www.perotsystems.com ) ... Systems revenue cycle solutions available to Amerinet,s acute and ...
... Patent Covers High-throughput, Anchorage-independent Assay for Screening Compounds ... Falcon Genomics, Inc. announced today that it ... covering the Company,s Cancer BioChip System (CBCS) for ... in a high-throughput in vitro setting ...
Cached Medicine News:Health News:Study Finds Multitude of Bacteria on Human Skin 2Health News:Study Finds Multitude of Bacteria on Human Skin 3Health News:New Guidelines to Fight Obesity in Pregnancy Issued 2Health News:New Guidelines to Fight Obesity in Pregnancy Issued 3Health News:NGL Expands Global Network to Service Parts Logistics Customers 2Health News:NGL Expands Global Network to Service Parts Logistics Customers 3Health News:Perot Systems to Supply Revenue Cycle Solutions to Amerinet Members Nationwide 2Health News:Perot Systems to Supply Revenue Cycle Solutions to Amerinet Members Nationwide 3Health News:Falcon Genomics Awarded Patent for Innovative Cancer Test 2
... for applications such as vasectomy that require ... handpiece with six-foot cord accepts an assortment ... physician to have the flexibility to perform ... includes the unit, 1 handpiece, and the ...
... The 2201 is ideal for applications ... application of heat. , ,The autoclavable ... assortment of reusable thermal cautery electrodes, ... flexibility to perform a wide variety ...
No Scalpel Vasectomy Ring Clamp, 5 1/2" (14cm), gold finger rings...
Non-Cantilevered, "Teardrop" Ringed Forceps. ("fixation clamp") For vasectomy and other procedures. Ring ovoid approximately 6.0 mm in diameter....
Medicine Products: