Bertek/FDA digoxin settlement

FDA affirms that Jerome Stevens/Duramed's digoxin tablets do not have an approved ANDA under Nov. 21 settlement agreement between the agency and Mylan subsidiary Bertek. FDA acknowledges marketing application approval for only two digoxin products: Bertek/Amide's Digitek and Glaxo Wellcome's Lanoxin. Bertek and Amide sued FDA Oct. 4 to remove unapproved digoxin tablets from the market. The agency reiterated that oral digoxin products require a marketing application in a Nov. 24 proposed rule (1"The Pink Sheet" Nov. 27, In Brief)