On April 18, 2016 Heron Therapeutics, Inc. (NASDAQ: HRTX), reported that the U.S. Food and Drug Administration (FDA) has provided the Company with an update on its review of the New Drug Application (NDA) for SUSTOL (granisetron) Injection, extended release (Press release, Heron Therapeutics, APR 18, 2016, View Source;p=RssLanding&cat=news&id=2158021 [SID:1234510998]). The FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.

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SUSTOL is a long-acting formulation of the 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). SUSTOL is formulated utilizing Heron’s 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.