Congress Presses FDA On Zohydro Approval As Product Launch Nears
This article was originally published in The Pink Sheet Daily
Three Republican senators seek assurances about safeguards against, and monitoring for, abuse of Zogenix’s extended-release hydrocodone product, which is expected to reach commercial channels in early March.
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FDA draft guidance says there is no clear epidemiologic strategy for gathering the data to demonstrate that has reduced abuse; the agency outlines four possible kinds of abuse deterrence claims, three of which can be obtained through pre-market studies.
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee wants Risk Evaluation and Mitigation Strategies enhanced for all extended-release/long-acting opioids as it recommends 11-2, one abstention, against approval of Zogenix’s single-entity hydrocodone product.
US FDA received 110 designation requests in July, a high mark that reflects the 60 days needed to review such requests ahead of the 30 September statutory expiration; agency is allowing email submission of RPD and orphan drug designation requests during the COVID-19 pandemic and expects to roll out an online portal for orphan designation requests later this year.