Navigation Links
K-V Pharmaceutical Company Announces Completion of U.S. Food and Drug Administration Inspection and Approval to Return its First Product to Market
Date:9/10/2010

ST. LOUIS, Mo., Sept. 10 /PRNewswire-FirstCall/ -- K-V Pharmaceutical Company (NYSE:  KVa/KVb) announced today that it has received notice from the U.S. Food and Drug Administration ("FDA") of the successful completion of an inspection of the Company's facilities and approval to return its first product to market.  Under the Company's Consent Decree, successful FDA inspections of the Company's quality systems, processes and facilities are expected to be required before K-V is permitted to resume manufacturing and shipment of particular products.  During the week of August 16, 2010, the FDA undertook an inspection of the Company's quality systems, manufacturing processes and facilities focusing on the first product dosage form for reintroduction by the Company into the marketplace.  The inspection was successfully completed.

The Company received notification from the FDA on September 8, 2010 of approval to ship into the marketplace the first product approved under the consent decree, i.e. Potassium Chloride.   The Company expects that initial shipments of its Micro-K®10mEq and Micro-K® 8mEq will begin the week of September 13, 2010.   The FDA is expected to conduct additional inspections with respect to other Company products before deciding whether other products may be manufactured and marketed.

Greg Divis, President of Ther-Rx Corporation and Interim President and Chief Executive Officer of K-V Pharmaceutical Company, stated, "Today marks a significant milestone in our efforts to restore business operations at K-V.  The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current Good Manufacturing Practices ("cGMP") requirements.  We are committed to continuing to move K-V through further successful inspections and to obtain additional product approvals from the FDA."

About K-V Pharmaceutical
'/>"/>

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:5/26/2015)... WALTHAM, Mass. , May 26, 2015 /PRNewswire/ ... the 62 nd Annual Meeting of the ... methods of monitoring patient respiration in hospitals miss ... serious risks to patients. The findings conclude that ... by Respiratory Motion, Inc. more consistently protects patients ...
(Date:5/26/2015)... , May 26, 2015 Boehringer Ingelheim ... Administration (FDA) approved once-daily STIOLTO™ RESPIMAT ® ... been approved as a long-term, once-daily maintenance treatment ... pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ... or acute deterioration of COPD. COPD, ...
(Date:5/26/2015)... , May 26, 2015  Organovo Holdings, Inc. ... on delivering breakthrough 3D bioprinting technology, announced today that ... the Jeffries 2015 Healthcare Conference, to be held in ... 4, 2015.  Keith Murphy , Chairman and Chief ... recent key advances and partnerships. Details of ...
Breaking Medicine Technology:Eight Studies Find Capnography, Pulse Oximetry Can Leave Patients at Risk for Life-Threatening Respiratory Depression 2Eight Studies Find Capnography, Pulse Oximetry Can Leave Patients at Risk for Life-Threatening Respiratory Depression 3Eight Studies Find Capnography, Pulse Oximetry Can Leave Patients at Risk for Life-Threatening Respiratory Depression 4Eight Studies Find Capnography, Pulse Oximetry Can Leave Patients at Risk for Life-Threatening Respiratory Depression 5FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 2FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 3FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 4FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 5FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 6FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 7FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 8FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 9FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 10FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 11FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 12FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD 13Organovo Holdings, Inc. To Present at Jeffries 2015 Healthcare Conference 2Organovo Holdings, Inc. To Present at Jeffries 2015 Healthcare Conference 3
... may still seem radically innovative in the context of ... had been the norm for many years. In automobile ... vehicles with only occasional human oversight. The result has ... positive returns in profit and productivity. These days, only ...
... necessary to plan or evaluate anticoagulant therapy, ... hyperhomocystinemia, elevated factor VIII levels, dysfibrinogenemia, factor ... and to assess acquired conditions, such as ... others. Prothrombin levels are also monitored along ...
Cached Medicine Technology:Lab Automation Networks Proliferating 2Lab Automation Networks Proliferating 3Lab Automation Networks Proliferating 4Prothrombin Time Comes in Small (CLIA-Waived) Packages 2Prothrombin Time Comes in Small (CLIA-Waived) Packages 3
(Date:5/26/2015)... Viejo, CA (PRWEB) May 26, 2015 ... styles for Final Cut Pro X . ... suspenseful to simple and elegantly styled text. , ... in seconds. , ProTrailer Network can easily complement any ... style desired and within seconds can make professional looking ...
(Date:5/26/2015)... Ore. (PRWEB) May 26, 2015 ... association which provides talent development to credit union CEOs, ... for their employees to boost the bottom line. CUES ... program that has helped dozens of credit unions across ... According to a 2014-2015 Staff Benefits Report ...
(Date:5/26/2015)... May 26, 2015 Foot and ... Dr. Enzo J. Leone (Pasadena and Baltimore Divisions) ... the Maryland Podiatric Medical Association (MPMA) President from 2013 ... Leone received his Doctorate in Podiatric Medicine from Temple ... West Jersey Hospital in Voorhees, New Jersey. Dr. ...
(Date:5/26/2015)... Boston, MA. (PRWEB) May 26, 2015 ... Standing option in their online Master of Social ... Program sites and on the Charles River Campus, the ... , This Advanced Standing option is open ... by the Council on Social Work Education. Students entering ...
(Date:5/25/2015)... According to the National Library of Medicine, one ... degenerative eye disease. The National Library of Medicine also states ... dyskinesia , a rare disorder that causes sporadic muscle behavior ... these two diseases are more than a statistic – they’re ... shoes with his new autobiography “ The Way I ...
Breaking Medicine News(10 mins):Health News:Developers at Pixel Film Studios Release ProTrailer Network for Final Cut Pro X 2Health News:CUES Expects a Positive Return on Wellness with hubbub health™ 2Health News:CUES Expects a Positive Return on Wellness with hubbub health™ 3Health News:Foot and Ankle Specialists of the Mid-Atlantic, LLC Podiatrist Receives MPMA Service Award 2Health News:Boston University to Offer Online Master of Social Work Advanced Standing Option 2Health News:Boston University to Offer Online Master of Social Work Advanced Standing Option 3Health News:Joseph K. Chan Finds Faith from Disability in New Autobiography 2
... Studies show combo chemotherapy, new drug prolonged lives of ... News) -- Researchers report they prolonged survival for some ... the median survival is currently only about six months. ... called crizotinib shrank tumors in the majority of lung ...
... - Dasatanib, a medication currently approved as treatment for ... better responses as a first therapy than the existing ... Texas MD Anderson Cancer Center. The findings were ... Society of Clinical Oncology today, and published in the ...
... In a ... ahm are paying tribute to local people helping and inspiring others. , ... (PRWEB) June 5, 2010 -- i98FM and ahm ... ahm Local Hero Awards., , , , ,In a joint effort to recognise Illawarra residents ...
... ... 600 persons in drug rehabs and prisons , ... (PRWEB) June 5, 2010 -- President Narconon International, Clark ... unique Narconon® drug-free withdrawal and relapse prevention technology to Mexico. Accompanied by U.S. and ...
... ... promising to make online buying a simple, easy one-stop shopping experience. , ... (PRWEB) June 5, 2010 -- With online shopping ... many choices, shipping arrangements and payment procedures that it is easy to get confused, which ...
... to new research that will be presented on Saturday, June ... of Dental Sleep Medicine, nasendoscopy may help dentists predict oral ... flexible endoscope being inserted through the nasal cavity. The tip ... velopharynx and oro-/hypopharynx. OAT has been shown to be ...
Cached Medicine News:Health News:Researchers Report Treatment Headway Against Lung Cancer 2Health News:Researchers Report Treatment Headway Against Lung Cancer 3Health News:Second-line CML drug evokes faster response, fewer side effects, pivotal study finds 2Health News:i98 Fm And ahm Announce Local Hero Finalists 2Health News:i98 Fm And ahm Announce Local Hero Finalists 3Health News:Narconon Campaigns to Help Mexico Reduce Drug-related Violence in Sonora and Michoacan 2Health News:BestMassage.com Launches Its Brand New Customer-Focused Website 2Health News:Nasendoscopy proves useful in predicting treatment success in sleep apnea patients 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: