FDA Policy/General

CDER Rejects NDA for Oxycodone HCL; Hearing Offered

Federal Register notice: CDER has proposed to refuse approval of a Pharmaceutical Manufacturing Research Services (PMRS) NDA for oxycodone hydrochloride immediate-release oral capsules. The notice summarizes the grounds for the not approving the submission and offers PMRS an opportunity to request a hearing on the matter. 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.

CDER Rejects NDA for Oxycodone HCL; Hearing Offered

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