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.
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