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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.’
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.