Labeling changes similar to those requested by U.S. FDA and the EC's CPMP are required for brandname and generic triazolam products, the Canadian Health Protection Branch announces Jan. 31. The recommended period for continuous use of triazolam in Canada has been shortened from 21 days to 14 days. The recommended starting dose will be lowered to .125 mg, with a maximum daily dose of .25 mg. The new warnings section will include adverse reactions such as memory disturbance, abnormal thinking and behavioral changes, confusion, anxiety and depression. The HPB also is considering whether labeling changes should be implemented for other benzodiazepines.
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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.’
Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
