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# Wilson Disease Petition is Moot: FDA
- URL: https://www.fdaweb.com/wilson-disease-petition-is-moot-fda/
- Published: 2018-02-14T12:00:00.000Z
- Updated: 2026-09-14T23:22:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140755

FDA says its 2/7 approval of an ANDA for trientine hydrochloride (Valeant’s Syprine) to treat Wilson disease renders moot an 8/17/17 petition requesting such an approval. The agency [response](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-5027-0010&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the petition “asserted that the approval of an ANDA for trientine hydrochloride will make available a competitive version of a life-supporting, daily-administered drug.” FDA says it “remains committed to increasing the accessibility of safe, effective treatments for Wilson disease.”