PITTSBURGH—The U.S. Food and Drug Administration has approved Mylan Inc.’s generic version of a high blood pressure patch, according to a July 19 news release.
The FDA approved Mylan’s Abbreviated New Drug Application (ANDA) for Clonidine Transdermal System USP, 0.1 mg/day, 0.2 mg/day and 0.3 mg/day.
The brand name version of the drug is made by German drugmaker Boehringer Ingelheim.
Clonidine Transdermal System had U.S. sales of approximately $313 million for the 12 months ending March 31, 2010, according to IMS Health. Mylan said the product is available for immediate shipment.
“Clonidine is in a class of medications called centrally acting alpha-agonist hypotensive agents,” according to according to an information page on PubMed Health. “It works by decreasing your heart rate and relaxing the blood vessels so that blood can flow more easily through the body.”
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.
