March 12, 2018 / 7:38 AM / 5 months ago

BRIEF-Hikma Gets U.S. FDA Response On ANDA For Generic Version Of GSK's Advair Diskus

March 12 (Reuters) - Hikma Pharmaceuticals Plc:

* UPDATE STATUS ON ANDA FOR GENERIC ADVAIR DISKUS

* HAS RECEIVED A RESPONSE FROM U.S. FDA IN RELATION TO ITS ANDA FOR ITS GENERIC VERSION OF GLAXOSMITHKLINE'S ADVAIR DISKUS

* REMAINED OUTSTANDING ISSUE REGARDING CLINICAL ENDPOINT STUDY, IN RESPONSE, DECIDED TO ENGAGE IN FDA'S DISPUTE RESOLUTION PROCESS​

* HIKMA HAS ALREADY FINALISED PLANNING OF A NEW CLINICAL STUDY AND EXPECTS TO START PATIENT ENROLMENT IN COMING WEEKS

* ‍HIKMA ANTICIPATES BEING ABLE TO SUBMIT A RESPONSE TO FDA WITH NEW CLINICAL DATA AS EARLY AS POSSIBLE IN 2019​ Source text for Eikon: Further company coverage:

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