Pozen's PA8140/PA32540 receives a complete response letter from FDA citing issues at a facility of a third party supplier of an active Ingredient

28-04-2014 Business Wire HealthComments (0)

PharmaceuticalPozen

Pozen (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets have received a complete response letter (CRL) from the US Food and Drug Administration (FDA). A CRL is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA)

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