Navigation Links
Mylan Reports That the FDA Determined That All Accusations Were Unfounded
Date:7/28/2009

PITTSBURGH, July 28 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today reported that in addition to the press release it issued on Sunday, the company proactively and as a courtesy had contacted the U.S. Food and Drug Administration (FDA) over the weekend to bring to its attention a recent news article. As a result, the FDA visited the company's Morgantown, W.Va., manufacturing facility Monday morning and has determined that the baseless accusations in the article were unfounded. The FDA noted there was no evidence of any data deletion. All data was reviewed and was present and accounted for; the Agency agreed that this was a minor Standard Operating Procedures (SOP) deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan.

Mylan Chairman and CEO Robert J. Coury said: "I want to first thank the FDA for responding as quickly as it did in light of the seriousness of these unfounded accusations. I hope that these actions only reaffirm Mylan's long-standing reputation as one of the industry's highest quality manufacturers with a management team that has an unyielding commitment to adhere to the highest quality standards. I also want to thank all of the employees in Morgantown for their continued dedication, hard work and commitment to uphold one of the industry's highest quality standards. As far as the abnormal trading volume in our stock yesterday, the only thing I have to say is that there is no one in a better position to speak about these issues for a company than the standing fiduciaries, whether it is the senior management of the company or any regulatory agency. I would hope that the market and our stakeholders take note of this."

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Mylan Reiterates and Stands Behind Its 48-Year Commitment and Track Record of Quality
2. Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol
3. Mylan Declares Quarterly Preferred Stock Dividend
4. Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel(R)
5. Mylan Schedules Second Quarter 2009 Financial Results Conference Call and Live Webcast
6. Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)
7. Mylans Chief Operating Officer Heather Bresch to Testify Before Congress Concerning Patent Settlements Between Brand and Generic Pharmaceutical Companies and Tactics That Delay Market Entry of High Quality, Affordable Generic Drugs
8. Mylan Announces Successful Matrix Delisting Offer
9. Mylan Announces Change in Board Leadership
10. Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)
11. Mylan Schedules First Quarter 2009 Financial Results Conference Call and Live Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2017)... ... , ... A 2-in-1 bottleless water appliance provides both purified ... Texas, here are the ways in which this technology can benefit dental offices: ... fresh, oxygenated water, with both cold and hot options. , Convenience for Dentists ...
(Date:4/23/2017)... , ... April 23, 2017 , ... ... managed services announced the achievement of Cisco Select certification and SMB specialization. ... United States. , In earning the Select Certification, Altura fulfilled the ...
(Date:4/22/2017)... (PRWEB) , ... April 22, ... ... Administration of Eastern Pennsylvania has named PROSHRED® Security of Philadelphia its ... Heron-Doerr, PROSHRED® Philadelphia specializes in providing information destruction , recycling, ...
(Date:4/22/2017)... ... 22, 2017 , ... Brian Emmer brings more than 25 ... Business Development at OAKWORKS, Inc. Mr. Emmer is responsible for the leadership ... for the company. Recognized industry-wide as a healthcare innovator, Emmer has executive ...
(Date:4/21/2017)... ... ... An April 10 article in the Daily Mail describes the ... deal about prehistoric ice-age dental practitioners and their primitive and, no doubt, painful techniques. ... dental matter, and that teeth were then filled with bitumen, a substance similar to ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)...   ZappRx, Inc ., a digital health company focused ... announced it closed $25 million in Series B funding led ... in Seattle that is part of ... Series B round included participation from SR One , ... GV (formerly Google Ventures). As part of the financing, ...
(Date:4/20/2017)... , April 20, 2017 Research and ... Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, ... report to their offering. ... The global pharmacogenomics market was valued at US$ 7,167.6 Mn ... by 2024, expanding at a CAGR of 5.6% from 2016 ...
(Date:4/20/2017)... , April 20, 2017 NeuroVive ... ("NeuroVive") today announced positive preclinical results demonstrating ... compound for non-alcoholic steatohepatitis (NASH), in an ... NV556 has previously shown similar ... model. Today, NeuroVive,s scientists present novel data ...
Breaking Medicine Technology: