Trials & Filings

FDA Accepts Zalviso NDA

AcelRx pain management system to be reviewed

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

AcelRx Pharmaceuticals‘ NDA for Zalviso was accepted for filing by the FDA. The acceptance indicates the FDA has determined that the application is sufficiently complete to permit a substantive review. The NDA, submitted on September 27, 2013, seeks approval for the marketing and sale of Zalviso for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The NDA submission is based primarily on data from a Phase III registration program that included two...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters