FDA Issues Complete Response Letter for Zalviso
AcelRx announced that the FDA has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Zalviso (sufentanil sublingual tablet system). Zalviso is a pre-programmed, patient-activated, non-invasive, handheld analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
The CRL requests for additional information on the Zalviso System to ensure proper use of the device. The FDA also requested to include provision of bench data demonstrating a reduction in the incidence of optical system errors, which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product.
AcelRx has already submitted amendments to the NDA prior to the issued CRL, but the FDA has not yet reviewed it.
For more information call (650) 216-3500 or visit AcelRx.com.