FDA Policy/General

FDA Denies Hearing on CDER Denial of Oxycodone NDA

Federal Register notice: FDA’s chief scientist has denied a request for a hearing on a CDER proposal to refuse approval of a Pharmaceutical Manufacturing Research Services (PMRS) NDA for oxycodone hydrochloride immediate-release oral capsules. The notice summarizes the grounds for not approving the submission. On 11/16/2017, the drug review division issued a complete response letter to PMRS and described the specific deficiencies. They included issues with the proposed labeling describing abuse-deterrent properties, and the safety and purity of the excipients intended (but not shown) to confer abuse deterrent properties were not adequately characterized. Additionally, the letter described additional deficiencies related to chemistry, manufacturing, and controls and current good manufacturing practice requirements. To view the notice, click here.

FDA Denies Hearing on CDER Denial of Oxycodone NDA

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