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# Heron NDA for Sustol Moves to Labeling Discussions
- URL: https://www.fdaweb.com/heron-nda-for-sustol-moves-to-labeling-discussions/
- Published: 2016-04-18T12:00:00.000Z
- Updated: 2026-09-14T20:55:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135395

> Heron Therapeutics says it has begun labeling discussions with FDA over an NDA resubmission for its 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 for the submission was 1/17, and it has been extended twice while the agency completed its review. In notifying the company about the labeling discussions, the agency said there are no substantive deficiencies in the NDA, according to Heron.  
>  
> 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 trial 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.