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# FDA Extends Review of Heron NDA Resubmission
- URL: https://www.fdaweb.com/fda-extends-review-of-heron-nda-resubmission/
- Published: 2016-03-01T12:00:00.000Z
- Updated: 2026-09-15T02:39:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134932

> FDA has delayed a review action on a Heron Therapeutics NDA resubmission for Sustol (granisetron) extended release injection, indicated for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The original user fee goal date was 1/17, which was extended until late February. Now, according to the company, the action date has been extended again with an undisclosed new action date.  
>  
> In 3/2013, FDA issued a complete response letter for the drug, asking that the company refine a chemistry, manufacturing and controls product quality analytical test method, and address deficiencies identified during facility pre-approval inspections. The NDA includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study involving more than 900 patients receiving HEC regimens. Data from an earlier Phase 3 study of more than 1,300 patients, which were previously submitted to the agency, demonstrated Sustol’s efficacy in preventing acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens, the company says.