Foreign marketing data for classes of OTC drugs without specific dosage instructions should be based on annual sales of the active ingredient rather than the finished product, raw material supplier Haarmann & Reimer states in March 21 comments on FDA's "material time, material extent" proposed rule.
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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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Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
