The Medical Letter TML n. 5/2014
Nr. 05 del 01/03/2014
TML n. 5/2014 – IN BREVE: Khedezla: un nuovo prodotto a base di desvenlafaxina
La FDA ha approvato l’immissione in commercio di un’altra formulazione a rilascio prolungato contenente desvenlafaxina (Khedezla-Par/Osmotica, negli USA; non disponibile in commercio in Italia), un inibitore della ricaptazione della serotonina e della noradrenalina (IRSN), per il trattamento della depressione. È la terza formulazione di desvenlafaxina a rilascio prolungato che si è resa disponibile negli Stati Uniti. Khedezla è stato approvato secondo la procedura 505(b)(2), una NDA (new drug application, domanda di approvazione per un nuovo farmaco) che si basa sulle conclusioni della FDA relative alla sicurezza e/o efficacia di un farmaco approvato in precedenza.
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