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Neuromed's Extended Release Hydromorphone Gets Committee Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Exalgo will be another test of FDA's willingness to approve opioids in the absence of a class-wide REMS.

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Onsolis' REMS Is Not Template For Long-Acting Opiates - FDA

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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Each week, "The Pink Sheet" presents commentary on some of the week's most interesting business deals, contributed by the editors of the IN VIVO blog. Visit the blog at

Opioids Pending At FDA Held Up By Anti-Abuse Claims, Not REMS Planning

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

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