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# Purdue Resubmits Butrans Petition to FDA
- URL: https://www.fdaweb.com/purdue-resubmits-butrans-petition-to-fda/
- Published: 2017-04-12T12:00:00.000Z
- Updated: 2026-09-14T22:17:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138430

Purdue Pharma has resubmitted its 3/27 [petition](https://www.fdaweb.com/purdue-wants-butrans-follow-on-restrictions/) asking FDA to place specific restrictions on follow-on products citing its Butrans (buprenorphine) transdermal system for transdermal administration as the reference-listed drug. The company says the requirements are necessary to ensure that any follow-on products are as safe and effective as Butrans. The [resubmission](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-2230-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that representatives of the FDA Office of Regulatory Policy asked that it be turned in.