Navigation Links
KV Pharmaceutical Enters Into Consent Decree With FDA
Date:3/2/2009

Decree outlines path forward to resume manufacturing at KV facilities

ST. LOUIS, March 2 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb) today announced that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing and distribution. The decree provides a series of measures that, when satisfied, will permit KV to resume the manufacture and distribution of products marketed by its subsidiaries, ETHEX and Ther-Rx. The Company is working expeditiously to satisfy the requirements and expects to provide further information in upcoming communications.

As part of the consent decree, KV has agreed not to market products it manufactures until it has satisfied certain requirements designed to demonstrate compliance with FDA's current good manufacturing practices (CGMP) regulations. KV has also agreed that it will not distribute certain products, including its prenatal vitamins and hematinic products, until the products are approved by FDA's ANDA or NDA processes.

"We have been working diligently with the FDA for the last two months to reach agreement on a clear path forward to permit KV to resume manufacturing and marketing its products," said David A. Van Vliet, KV's Interim Chief Executive Officer. "Since December, when new management took over at KV, our team has taken significant steps to enhance our systems and procedures, and we will continue to do so. We look forward to cooperating with the FDA during this process that will facilitate our return to the market. Predicting the timing for the return and the ultimate product assortment that we will market are presently very difficult due to the range of variables that must be managed. As we gain certainty, we will notify customers and all other stakeholders."

The consent decree provides that, before resuming manufacturing, KV will have an independent thir
'/>"/>

SOURCE KV Pharmaceutical Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related biology technology :

1. Angiotech Pharmaceuticals, Inc. announces new Senior Secured Term Loan and Credit Facilities
2. Epistem Announces Research and Development Collaboration With a Major Pharmaceutical Company
3. Simcere Pharmaceutical Group to Announce 2008 Fourth Quarter and Full Year Earnings On Thursday, March 12, 2009
4. Immtech and Beijing Pharmaceutical Group Co. Sign Memorandum of Understanding to Explore Developing Strategic Business Alliance
5. Trubion Pharmaceuticals Inc. Announces Work-Force Reductions and Restructuring
6. VIA Pharmaceuticals Announces Grant of New Patent on Lead Compound VIA-2291
7. Poniard Pharmaceuticals Announces New Efficacy and Safety Data from a Phase 2 Picoplatin Trial in Patients with Prostate Cancer
8. Cerimon Pharmaceuticals Initiates Phase III Clinical Studies to Evaluate Its Topical Diclofenac Sodium Patch for Mild-to-Moderate Pain
9. Eiger BioPharmaceuticals Raises $7.1 Million A Round
10. Angiotech Pharmaceuticals announces time change of conference call and webcast
11. Mindset BioPharmaceuticals (USA) Inc Obtains Notice of Allowance for European Patent Related to Use of Insulin Sensitizers in Senile Dementia, Dementia and Memory Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... Boca Raton, FL (PRWEB) August 27, 2014 ... that are applied through the use of a handheld ... consumers across the United States. , The brand ... care unit. BIOEQUA researchers were surprised to learn that ... to be made extremely small and delivered directly to ...
(Date:8/27/2014)... WriteResult, LLC – a premier provider ... shown superiority when it comes to meeting the needs ... portion of their most recent study closeout on-time and ... WriteResult’s digital writing platform to collect Patient Reported Outcomes ... complete drew data from a number of assessments including ...
(Date:8/26/2014)... Bellingham, WA (PRWEB) August 26, 2014 ... visions for next-generation wearable technology, and inspiration for ... highlights at this year’s brighter, busier SPIE ... California, Convention Center. More than 4,400 international scientists, ... conferences, courses, an exhibition, and industry sessions sponsored ...
(Date:8/26/2014)... has just been added to the growing case ... the next big thing in the high-tech world ... An international collaboration of researchers led by a ... Lawrence Berkeley National Laboratory (Berkeley Lab) has reported ... in photo-excited MX2 materials. The recorded charge transfer ...
Breaking Biology Technology:BIOEQUA'S EQUA ESSENTIAL Product Line Redefines Skin Care & Now Available in America 2A Perfect Record: WriteResult Maintains a 100% On-Time ePRO Record with Latest Irritable Bowel (IBS) Study Data Lock 2Brighter, Busier SPIE Optics + Photonics Draws International Crowd to San Diego 2Brighter, Busier SPIE Optics + Photonics Draws International Crowd to San Diego 3Brighter, Busier SPIE Optics + Photonics Draws International Crowd to San Diego 4Competition for graphene 2
... Laboratories , a leading single source provider of contract ... of analytical testing and ... testing is the perfect complement to our portfolio ... of Microtest Laboratories ( www.microtestlabs.com ). "By ...
... Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ), a biopharmaceutical company focused ... at the following meetings:, BIO 2009 Business Forum, ... a.m. - 9:35 a.m. Eastern, Location: Georgia World Congress ... Senior Vice President, Medical Affairs and, ...
... Transgenomic Inc. (OTC Bulletin Board: TBIO) announces the following Webcast: , ... Conference Call, ... Where: http://www.transgenomic.com/events.asp?id=6 , ... at, ...
Cached Biology Technology:Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services 2Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services 3Reminder: Transgenomic Inc. Announces First Quarter 2009 Earnings Release Conference Call Webcast 2
(Date:8/27/2014)... health advocates, campaigns against trans-fats have largely succeeded ... taking aim at sugar for its potential contributions ... are still wrangling over the best way to ... an article in Chemical & Engineering News ... American Chemical Society. , In the article, Stephen ...
(Date:8/27/2014)... that piglets can be weaned later with no negative ... the study at the University,s Roseworthy campus, published in ... important finding for pig producers. It allows improvements in ... "Sows don,t usually start their oestrous cycles again during ... been weaned," says Ms Alice Weaver, PhD candidate with ...
(Date:8/27/2014)... of Warwick research finds , Gamblers show the ... new research has shown. , Researchers, led by Dr ... Psychology, conducted tests that found that both human gamblers ... high-value than low-value rewards. , Published in Biology ... show the important role that memories of previous biggest ...
Breaking Biology News(10 mins):Piglet weaning age no bar to litter frequency 2Gamblers are greedy bird-brains, University of Warwick research finds 2
... Calif. ( http://www.ucr.edu ) A University of ... a group of researchers that have made important ... oscillator, which could serve as a timekeeping device ... assistant professor of mechanical engineering at UC Riverside,s ...
... Wistar Institute have developed a mathematical method for classifying ... brain cancer, through variations in the way these tumor ... predicting the subclasses of glioblastoma tumors with 92 ... physicians to accurately predict which forms of therapy would ...
... Are you active at your job? If you,re like most ... A team of researchers at the University of Iowa ... on movement. Yet the group found that police officers burn ... holding a baby or washing dishes. "We find that ...
Cached Biology News:Artificial cells and salad dressing 2Wistar scientists develop gene test to accurately classify brain tumors 2Wistar scientists develop gene test to accurately classify brain tumors 3Workers, get up and move 2Workers, get up and move 3
Agarose-LE, 500 g. Suitable for soft agarose cloning. Nuclease-free.Gel point (1.5%): 36 1.5 C, EEO (-mr): 1200 g/cm2. Category: Nucleotides & Enzymes & Biochemicals, Ultrapure Biochemicals ....
Request Info...
Request Info...
Limit of detection: <5 pg/ml...
Biology Products: