March 8, 2018 / 9:20 PM / 2 months ago

BRIEF-AcelRX Plans To Resubmit The Dsuvia New Drug Application In Q2

March 8 (Reuters) - Acelrx Pharmaceuticals Inc:

* ACELRX ANNOUNCES RECEIPT OF TYPE A FDA MEETING MINUTES AND PLANS TO RESUBMIT THE DSUVIA NEW DRUG APPLICATION IN Q2 2018

* ACELRX PHARMACEUTICALS INC - ‍INTENDS TO RESUBMIT NDA IN Q2 OF 2018 AFTER COMPLETION OF HF STUDY​

* ACELRX PHARMACEUTICALS - ‍RECEIPT OF OFFICIAL JANUARY 2018 TYPE A MEETING MINUTES FROM U.S. FDA RELATING TO ACELRX’S DSUVIA NDS

* ACELRX PHARMACEUTICALS INC - ‍ACELRX PROPOSED POTENTIAL RESOLUTIONS FOR TWO MAIN POINTS IDENTIFIED IN CRL RECEIVED FROM FDA IN OCTOBER 2017​

* ACELRX PHARMACEUTICALS INC - CO PROPOSED INSTEAD TO REDUCE MAXIMUM DOSE IN LABEL TO NOT EXCEED 12 TABLETS WITHIN A 24-HOUR PERIOD

* ACELRX PHARMACEUTICALS INC - CO SUBMITTED TO FDA UPDATED DFU, AND A REVISED PROTOCOL FOR HF STUDY REQUIRED TO VALIDATE EFFECTIVENESS OF DFU CHANGES​ Source text for Eikon: Further company coverage:

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