FDA's Letter to Heron Therapeutics (HRTX) Over Sustol Approval
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Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
August 10, 2016 8:30 AM EDTSUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens A standard of care in the treatment of breast cancer and other cancer types, AC-based regimens are among the most commonly prescribed highly emetogenic chemotherapy regimens as defined by both the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) U.S. commercial launch of SUSTOL is planned for the fourth quarter of 2016... More
