Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48-Year Exemplary Record of Quality
No deficiencies found, no FDA "483" issued
PITTSBURGH, Aug. 13 /PRNewswire-FirstCall/ -- Mylan Inc. (NASDAQ: MYL) today announced that the U.S. Food and Drug Administration (FDA) has released its official and final report regarding the agency's review of allegations made in a July newspaper article concerning the company's Morgantown, W.Va., manufacturing facility. The newspaper article, which included unfounded and highly inaccurate allegations, was based on improperly obtained documents, uninformed third-party commentary and anonymous sources. The final FDA report closes the inspection with no deficiencies found and no FDA "483" issued.
Mylan Chairman and CEO Robert J. Coury said: "I would like to thank the FDA for thoroughly reviewing this matter. The baseless speculation that was caused by a highly irresponsible and sensational newspaper article with a biased agenda was entirely unnecessary. Our customers and stakeholders recognize that there is no one in a better position to speak about issues such as these than a company's senior management or the applicable regulatory agency. It would be a mistake for anyone to rely on uninformed sources.
"Mylan's manufacturing facilities -- especially our plant in Morgantown -- have always represented the gold standard when it comes to quality. Without ever getting complacent, our entire management team and all of our employees continue to demonstrate an unyielding commitment to sustain the highest of quality standards. I would like to thank all of our employees for their continued hard work and execution, and I am pleased that this investigation is formally behind us."
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.