FDA accepts Heron’s painkiller re-submission; splits Blueprint Medicines’ NDA for avapritinib

San Diego Biotechnology Network
San Diego Biotechnology Network
FDA accepts Heron's painkiller re-submission; splits Blueprint Medicines' NDA for avapritinib

? Nearly six months ago, Heron was handed an unexpected rejection by the FDA due to manufacturing concerns for HTX-011 ? a long-acting non-opioid painkiller for post-surgical analgesia that would?ve rivaled Pacira Pharmaceuticals? J&J-partnered, long-acting post-op painkiller Exparel. On Monday, the San Diego company said the US regulator had accepted its resubmitted marketing application. The FDA is expected to make its decision by March 26.

? The FDA has put a wrench in the works for Blueprint Medicines. The agency wants