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:2/12/2016)... (PRWEB) , ... February 12, 2016 , ... ... Lean Leadership Series at Zuckerberg San Francisco General Hospital on April 5-7. The ... new behaviors and create new habits. The workshops cover a broad range of ...
(Date:2/12/2016)... ... February 12, 2016 , ... Every winter, someone is ... winter the West Penn Burn Center, part of the Allegheny Health Network, ... to bring you the “Space Heaters Need Space” campaign. , “Space Heaters ...
(Date:2/12/2016)... ... 12, 2016 , ... AssureVest Insurance Group, a locally owned insurance firm with ... will raise funds earmarked to purchase computers and software for Mrs. Harrison’s 2nd and ... is in a low-income area and has more than 60 2nd and 3rd graders ...
(Date:2/12/2016)... ... ... Vail knee specialist Robert LaPrade, MD, PhD was named one of ... of physicians establishing, leading and partnering with ambulatory surgery centers across the United States. ... also known as an ASC, is a modern health care facility focused on providing ...
(Date:2/12/2016)... , ... February 12, 2016 , ... ... the Pittsburgh metro area, celebrates the beginning of the latest charity campaign in ... social skills through art. Donations to this worthy cause are currently being accepted ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... Feb. 12, 2016  Sequent Medical, Inc. announced today ... to evaluate the safety and effectiveness of the WEB™ ... ruptured intracranial aneurysms.  Prof Laurent Spelle , MD, ... Paris, France and Principal Investigator of ... France and Germany.  Although patients with ...
(Date:2/12/2016)... , Feb. 12, 2016  Aralez Pharmaceuticals Inc. (Nasdaq: ... announced the Company will ring the Nasdaq Closing Bell ... New York at 4:00 p.m. ET on ... Aralez. Adrian Adams , will perform ... 3:50 to 4:00 p.m. ET.  A live webcast will ...
(Date:2/12/2016)... February 12, 2016 ... auf den ungedeckten medizinischen Bedarf bei Lungen- ... seines klinischen Forschungsprogramms bekannt. Das Programm, das ... Verbesserungen ihrer respiratorischen Funktionen und anderer klinischer ... ein Medizintechnikunternehmen, das sich auf den ungedeckten ...
Breaking Medicine Technology: