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Pharmaceuticals / Regulatory Affairs

FDA Denies Hearing on Rejection of Oxycodone NDA

Nov. 6, 2018

The FDA denied a request from Pharmaceutical Manufacturing Research Services (PMRS) for a hearing on the agency’s refusal to approve the drugmaker’s oxycodone NDA.

CDER issued a complete response letter to PMRS in November 2017 indicating it could not approve the NDA in its current form, citing the lack of data on the drug’s pharmacodynamic properties when ground and snorted — among other deficiencies.

The agency also noted inadequate data to show the presence of excipients in the formulation can deter abuse by injection. The data were also insufficient to rule out the possibility that the proposed formulation could lead to more widespread abuse, the agency said.

In response to the CRL and a subsequent notice, the company requested a hearing on the grounds for the denial. CDRH’s Chief Scientist Denise Hinton determined PMRS did not raise a “genuine and substantial issue of fact” justifying a hearing.

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