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:10/13/2017)... IL (PRWEB) , ... October 13, 2017 , ... ... which established the certification process to promote standards of excellence for the field ... Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of the ... a national organization of elder law and special needs planning attorneys. “Membership in ElderCounsel ... also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to host ... items from across the nation, this holiday-themed event will raise funds and awareness for ... The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 p.m.) ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... The Rebound mobile app is poised to become ... tide of prescription drug addiction. The app empowers users to ... stepping down their dosage in a safe, controlled manner while ... the first 100,000 people to sign up will enjoy 3 ... ...
(Date:9/27/2017)... Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global digital ... its MyDario product is expected to appear on The Dr. Oz Show ... Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked off ... The segment features ...
(Date:9/22/2017)... , Sept. 22, 2017  As the latest ... Senators Bill Cassidy (R-LA) and Lindsey ... notes that the medical device industry is in an ... device tax, the 2.3% excise tax on medical device ... they also want covered patients, increased visits and hospital ...
Breaking Medicine Technology: