Thursday, May 1, 2008

Mylan Announces Final FDA Approval for Trandolapril Tablets

Mylan Inc. 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.

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