Digoxin marketing requirements

Manufacturers of oral digoxin must submit an NDA or ANDA to continue to market their products, FDA says in Nov. 24 proposed rule. The rule revokes premarket approval of digoxin products under batch certification and says that generic versions of digoxin must reference Glaxo Wellcome's Lanoxin. Bertek and Amide recently sued FDA to remove Jerome Stevens/Duramed's digoxin from the market because it does not have an approved application (1"The Pink Sheet" Oct. 16, p. 7)

Manufacturers of oral digoxin must submit an NDA or ANDA to continue to market their products, FDA says in Nov. 24 proposed rule. The rule revokes premarket approval of digoxin products under batch certification and says that generic versions of digoxin must reference Glaxo Wellcome's Lanoxin. Bertek and Amide recently sued FDA to remove Jerome Stevens/Duramed's digoxin from the market because it does not have an approved application (¹ (Also see "Bertek And Amide Sue FDA To Remove Unapproved Digoxins" - Pink Sheet, 16 Oct, 2000.)).