Heron Therapeutics re-submits NDA to FDA for Sustol (granisetron) Injection, extended release, to treat CINV.
Heron Therapeutics, Inc. announced that it has resubmitted its New Drug Application (NDA) to the FDA for Sustol (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by the FDA.
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