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# FDA Asked to Stay Roxybond NDA Approval
- URL: https://www.fdaweb.com/fda-asked-to-stay-roxybond-nda-approval/
- Published: 2017-05-18T12:00:00.000Z
- Updated: 2026-09-14T22:24:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138725

Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA to stay its approval of an Inspirion Delivery Sciences NDA for Roxybond (oxycodone HCl) tablets. The PMRS [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-3064-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) asks the agency stay the effective date of approval of the NDA with labeling claims pertaining to chronic use and abuse deterrence until FDA responds to two earlier PMRS petitions raising issues about abuse deterrence in opioids and about deficiencies PMRS sees in the Inspirion data.

The organization’s 3/2017 petition asked that FDA revoke all immediate-release opioid drug product labeling supporting use for treating chronic pain and instead make the indication for acute pain in a limited duration.

“FDA has approved the Inspirion NDA without having provided a substantive response to the PMRS petitions, yet, as discussed in detail herein, that approval is contrary to several of the actions requested and underlying issues raised in the pending PMRS petitions,” the petition says. “In addition, and as also discussed herein, there are significant flaws in the study methodology, data, and information submitted by Inspirion, and ostensibly relied upon by FDA in approving the Inspirion NDA.”