Committee will also “explore ways of further evaluation” of the safety of Pfizer’s Bextra and COX-2s approved in Europe, such as Merck’s Arcoxia. FDA also expects discussion of broader NSAID category, at least for “context.”
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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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