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:1/20/2017)... ... ... "TransFlare 4K Mystique comes with 44 colorful mysterious transitions that are fully ... - CEO of Pixel Film Studios. , TransFlare 4K Mystique contains 44 lens ... and light leak transitions have a very high-dynamic range for super smooth falloff. Simply ...
(Date:1/20/2017)... ... 2017 , ... “The Angel”: a heartwarming and earnest tale of faith ... his children. “The Angel” is the creation of published author, Marjorie Lund-Fontaine, a former ... impassioned writer. , When asked of her new book, Marjorie says, “‘The Angel’ was ...
(Date:1/20/2017)... Farmville, NC (PRWEB) , ... January 20, 2017 ... ... the vPEP ® Oscillating Positive Expiratory Pressure (OPEP) device, was featured in ... article by Doug Pursley, MEd, RRT-ACCS, FAARC, “Analysis of Three Oscillating Positive ...
(Date:1/20/2017)... ... ... is God’s Lighthouse”: a moving and colorful collection of prayers that reminds readers ... author, Gene Gaapf, a retired truck driver, and a long-time writer, whose published works ... school and have many different titles,” Gaapf mentions about his different works. “I am ...
(Date:1/19/2017)... ... January 20, 2017 , ... Today, the Centers for Medicare & Medicaid Services ... Alternative Payment Models (APMs) in 2017. Clinicians who participate in APMs are paid for ... part of the Administration’s effort to build a system that delivers better care and ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... Jan. 19, 2017 Conference Call and Webcast to Follow ... today announced it will release results for the fourth quarter of ... ... a conference call at 4:30 PM ET on Wednesday, February 15, ... year 2016 financial results and other corporate activities. To participate in ...
(Date:1/19/2017)... N.J. , Jan. 19, 2017 Many ... $100 for their medication when a pharmacy just a ... exact prescription.  To alleviate this problem Medicationdiscountcard.com ... patients to see exactly how much their medication will ... Shopping Made Easy ...
(Date:1/19/2017)... , January 19, 2017 According to ... for cryotherapy is set to witness a CAGR of 6.5% during ... America will continue to be the leading market for ... ... Suppliers are emphasizing on ensuring affordable and adequate supply of gas ...
Breaking Medicine Technology: