Posted by Michael Wonder on 10 May 2018
AcelRx resubmits new drug application for Dsuvia
9 May 2018 - AcelRx Pharmaceuticals today announced the resubmission of the new drug application for DSUVIA with the U.S. FDA.
AcelRx anticipates that the FDA will acknowledge acceptance of the NDA within 30 calendar days of the resubmission date. AcelRx expects a six-month review by the FDA with a projected PDUFA date in the fourth quarter of 2018.
DSUVIA (sufentanil sublingual tablet, 30 mcg), known as Dzuveo in Europe, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients. A positive opinion from the CHMP was recently issued recommending approval to the EMA for DZUVEO. A potential marketing authorisation from EMA is expected in the third quarter of 2018.
