FDA Delays PDUFA Date for Heron’s Chemo Treatment

Heron Therapeutics’ hopes for a quick FDA decision on its NDA for Sustol were scuttled as the agency pushed back its action date to late February, the company says.

Jan. 17 was the original PDUFA date for the injectable drug to treat chemotherapy-induced nausea. The Redwood City, Calif.-based drugmaker says the FDA has notified the company that is has not yet completed its review.