Heron Therapeutics announced that the review of its New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release could not be completed by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 by the US Food and Drug Administration (US FDA). According to the company, the US FDA anticipates taking action on SUSTOL New Drug Application in late February 2016. The company stated that SUSTOL is a long-acting formulation of the US FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).

According to the company, SUSTOL is formulated using its proprietary Biochronomer drug delivery technology and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.