On March 3, 2016 Heron Therapeutics, Inc. (NASDAQ:HRTX), reported that the U.S. Food and Drug Administration (FDA) has informed the Company that it anticipates concluding its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release, by early April 2016 (Press release, Heron Therapeutics, MAR 3, 2016, View Source [SID:1234509360]). Schedule your 30 min Free 1stOncology Demo! The Company is working closely with the FDA to facilitate the completion of its review.
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"We remain committed to SUSTOL and the benefit it may provide to patients suffering from chemotherapy-induced nausea and vomiting and continue to be optimistic regarding the FDA’s review of the SUSTOL NDA," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics. "We continue to be ready for the commercial launch of SUSTOL in the second quarter of 2016, if approved."
About SUSTOL (granisetron) Injection, extended release
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.