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Monday, 06/06/2016 1:44:53 PM

Monday, June 06, 2016 1:44:53 PM

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Heron Therapeutics, Inc. (NASDAQ: HRTX), announced today 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. The FDA has indicated that there are no substantive deficiencies in the NDA and has begun labeling discussions with the Company.

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.
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