Andrx Expects “Near Term” FDA Response To Petition Blocking Concerta Generics
McNeil’s citizen petition requests FDA apply additional bioequivalence requirements for Concerta ANDAs. With no patent exclusivity remaining on the innovator product, multiple generics could be approved if FDA rejects McNeil’s arguments.
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’