Neuromed's Extended Release Hydromorphone Gets Committee Review
This article was originally published in The Pink Sheet Daily
Exalgo will be another test of FDA's willingness to approve opioids in the absence of a class-wide REMS.
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FDA signaled it is moving ahead with action on short-acting opioid products - and their Risk Evaluation and Mitigation Strategies - on a case-by-case basis with the approval of BioDelivery Sciences International's buccal fentanyl product Onsolis for cancer breakthrough pain
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Opioid products awaiting FDA approval are not being put on hold for completion of a Risk Evaluation and Mitigation Strategy, said Office of New Drugs Director John Jenkins