Heron Therapeutics resubmits Sustol NDA to FDA

US specialty biotech group Heron Therapeutics (Nasdaq: HRTX) has resubmitted its New Drug Application (NDA) for Sustol (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens, to the US Food and Drug Administration (FDA).

Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The company anticipates a six-month review by the FDA. Sustol would be the first 5-HT3 antagonist approved for the condition, the company noted.

Early last year, Heron saw its shares plunge after the company revealed an around one-quarter delay to its timeline for the resubmission of the New Drug Application for Sustol (The Pharma Letter January 28, 2014). Heron has previously received two complete response letters from the FDA regarding filings for Sustol, most recently in 2013 when the FDA called for further data on the product candidate.