AcelRx Announces Zalviso NDA Accepted for Filing by FDA

Loading...
Loading...
AcelRx Pharmaceuticals
ACRX
announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review. "We are extremely pleased with the filing of our NDA for Zalviso, representing achievement of another critical milestone for AcelRx," stated Richard King, president and CEO of AcelRx. "Zalviso, if approved, will provide hospitalized patients with a non-programmable, non-invasive, patient-controlled treatment option for the management of moderate-to-severe acute pain with a rapid onset of pain relief compared to the commonly used, intravenous patient controlled analgesia systems that typically utilize morphine." 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
See full press release
Posted In: NewsGuidanceFinancingContractsFDALegalManagementGlobal
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...