Droperidol oral formulation will be discontinued in the U.K. March 31 following concerns from the Medicines Control Agency about potential effect on cardiac QT interval associated with chronic usage. Droperidol is marketed in the U.K. by Janssen as an anti-psychotic and anti-emetic. In the U.S., droperidol is available in injectable form and marketed as a generic and by Akorn as Inapsine. Akorn said it has not observed cardiac side effects; dosing is lower and less frequent than indicated in the U.K
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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.’
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
