Mylan Inc. today announced that its subsidiary Mylan Technologies Inc. has received final approval from the 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 U.S. sales of approximately $313 million for the 12 months ending March 31, 2010, according to IMS Health. The product is available for immediate shipment.
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.