Cautionary statements regarding flammability and burns for topical/inhalant products containing camphor or menthol must appear under the "Warnings" section of product labeling, FDA says in amending the OTC antitussive drugs final monograph.
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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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