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January 27, 2014
08:04 EDTHRTXHeron sees one-quarter delay to timeline for Sustol NDA resubmission
Heron Therapeutics announced an approximate one-quarter delay to the company’s timeline for the resubmission of the new drug application for Sustol to the U.S. Food and Drug Administration, the company’s product candidate for chemotherapy-induced nausea and vomiting. The company received notice last week from the supplier of the syringes used for Sustol injections that the production order of syringes manufactured for Heron, and scheduled to be used in the validation of the commercial manufacturing process for Sustol required for resubmission of the NDA, will be delayed due to equipment failure of an in-process quality control check. The equipment failure is not specific to Sustol or Heron, and remedial efforts are underway. “While the timing of our resubmission will be impacted by this delay, we expect it to have minimal impact on our projected timing of the launch of Sustol,” said Barry D. Quart, PharmD, CEO. “Subject to the FDA’s review and approval of the Sustol NDA, we project being in a position to launch Sustol in early 2015, which presents more optimal timing than potentially launching into the late 2014 holiday season.”
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