April 10, 2018 / 12:36 PM / 8 months ago

BRIEF-Abbvie And Neurocrine Biosciences Announce PDUFA Target Date Of Q3 2018 For Elagolix In Endometriosis Associated Pain

April 10 (Reuters) - Abbvie And Neurocrine Biosciences Announce Pdufa Target Date Of Q3 2018 For Elagolix In Endometriosis :

* ASSOCIATED PAIN

* FDA REQUIRES EXTENDED TIME FOR REVIEW OF ADDITIONAL INFORMATION IN NEW DRUG APPLICATION

* BASED ON ABBVIE'S REVIEW OF DATA, COMPANY REMAINS CONFIDENT IN NDA AND CONTINUES TO WORK WITH FDA TO BRING ELAGOLIX TO PATIENTS

* REGULATORY SUBMISSIONS FOR ELAGOLIX IN UTERINE FIBROIDS REMAIN ON TRACK

* PRESCRIPTION DRUG USER FEE ACT DATE HAS BEEN EXTENDED THREE MONTHS TO Q3 2018 FOR ELAGOLIX Source text for Eikon: Further company coverage:

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