PMRS Sues FDA Over Hearing on Rejected NDA

Pharmaceutical Manufacturing Research Services (PMRS) has filed a lawsuit against FDA in eastern PA federal court seeking an order to compel the agency to provide a hearing on its decision not to approve the company’s NDA for oxycodone hydrochloride immediate-release oral capsules (see earlier story). In the complaint, PMRS argues that it provided sufficient data, information and analyses that would legally entitle it for a hearing on the NDA rejection.

On 11/16/2017, CDER 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.