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# FDA Denies PMRS Requested Stay of Roxybond Approval
- URL: https://www.fdaweb.com/fda-denies-pmrs-requested-stay-of-roxybond-approval/
- Published: 2017-11-01T12:00:00.000Z
- Updated: 2026-09-14T22:59:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140022

FDA has denied a Pharmaceutical Manufacturing Research Services (PMRS) 5/11 petition to stay the effective date of the approval of Inspiron’s Roxybond (oxycodone hydrochloride) with labeling claims pertaining to chronic use and abuse deterrence until the agency issues substantive written responses to two earlier PMRS petitions. The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-3064-0030&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that while the PMRS 2/19/16 and 3/6 petitions address matters of general relevance to opioid products, neither presents a basis for FDA to stay the approval of Roxybond while it considers such issues.

Roxybond was approved 4/20 as the first immediate-release opioid with labeling describing abuse-deterrent properties.

In its response, FDA cites the three criteria for review of a petition for stay of action and explains how PMRS failed to demonstrate that it will otherwise suffer irreparable injury, failed to cite sound public policy grounds supporting a stay, and failed to demonstrate how the public health and other public health interests would be served by a stay.

“While we welcome your engagement and that of other stakeholders on this critical public health subject,” the letter tells PMRS, “we do not agree that the requested stay would be in the public interest….”