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)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.