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- Publication:2010/7/20
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Technologies Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day, the generic version of Boehringer Ingelheim's Catapres-TTS®, a treatment for hypertension.
Clonidine Transdermal System had
Currently, Mylan has 132 ANDAs pending FDA approval representing $92.7 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $21.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.
SOURCE Mylan Inc.