MAGNESIUM CITRATE LAXATIVE OTHER THAN IN ORAL SOLUTION is not allowed under the tentative final monograph for OTC laxatives, FDA told Purdue Frederick in a December letter. The Norwalk, Conn.-based firm had asked FDA in October 1994 to give monograph status to a formulation of magnesium citrate 25 g in a solid mixture that must be reconstituted before oral administration. The agency decided that the information provided by Purdue Frederick did not "support the requested revision."
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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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
