Heron Resubmits NDA For SUSTOL Injection In Chemotherapy-induced Nausea

(RTTNews) - Heron Therapeutics, Inc. (HRTX) said it has resubmitted its New Drug Application for SUSTOL (granisetron) injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy or highly emetogenic chemotherapy regimens, to the U.S. Food and Drug Administration.

Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act goal date within the next few weeks. The company expects a six-month review by the FDA.

The NDA filing includes data from the MAGIC study, Heron's recently completed, multi-center, placebo-controlled, Phase 3 study in patients receiving highly emetogenic chemotherapy agents.