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Mylan Announces Final FDA Approval for Trandolapril Tablets Print E-mail
29 Apr 2008

Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application  for Trandolapril Tablets, 1 mg, 2 mg and 4 mg

PITTSBURGH, PA, USA | April 29, 2008 | Mylan Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1 mg, 2 mg and 4 mg.

Trandolapril Tablets are the generic version of Abbott Laboratories' Mavik(R) Tablets. Brand and generic versions of this product had total U.S. sales of approximately $34 million for the 12 months ending Dec. 31, 2007, for the same strengths, according to IMS Health.

Mylan Inc., with operations in more than 90 countries, 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 second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

SOURCE: Mylan Inc.





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