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# FDA Delays PDUFA Action Date for Phathom’s Vonoprazan
- URL: https://www.fdaweb.com/fda-delays-pdufa-action-date-for-phathoms-vonoprazan/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153460

FDA says it will not act on the Phathom Pharmaceuticals NDA for vonoprazan as a treatment for erosive esophagitis on or before the 1/11 PDUFA action date. Phathom [says](https://www.globenewswire.com/news-release/2023/01/03/2582483/0/en/Phathom-Pharmaceutic%5B%E2%80%A6%5Dlication-Review-of-Vonoprazan-for-Erosive-Esophagitis.html?ref=fdaweb.com) the delay comes after the company reported on 8/2/22 it had detected trace levels of N-nitroso-venoprazan (NVP) in commercial batches and was working closely with the agency to obtain approval of a proposed acceptable daily intake limit, test method, and controls to address the impurity before releasing vonoprazan-based products to the market.

“While an acceptable daily intake limit for NVP has now been established by FDA…,” the company says, “FDA has requested additional stability data demonstrating that levels of NVP remain below that limit throughout the proposed shelf life of the product.” Phathom says it is in the process of generating additional stability data and discussing with FDA the nature and extent of such requested data.