Manufacturing issues hobble Heron's quest to market its long-acting non-opioid painkiller
The C-suite at Pacira likely sighed in relief on Wednesday, as their main rival, Heron Therapeutics, was handed an unexpected FDA rejection — related to manufacturing concerns — for a competing long-acting non-opioid painkiller for post-surgical analgesia.
The health regulator has asked for additional information related to Heron’s chemistry, manufacturing and controls and other non-clinical data — and has not identified any safety or efficacy issues, nor asked for extra clinical studies and data analyses for the drug, HTX-011, Heron said.
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