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# Phathom Resubmits Vonoprazan NDA
- URL: https://www.fdaweb.com/phathom-resubmits-vonoprazan-nda/
- Published: 2023-05-24T12:00:00.000Z
- Updated: 2026-09-14T18:34:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154522

Phathom Pharmaceuticals says it has resubmitted to FDA an NDA for vonoprazan, a novel first-in-class potassium-competitive acid blocker to treat erosive gastroesophageal reflux disease (erosive esophagitis). The company [says](https://investors.phathompharma.com/news-releases/news-release-details/phathom-pharmaceuticals-resubmits-erosive-gerd-new-drug?ref=fdaweb.com) the resubmission responds to an agency 2/2023 complete response letter relating to specifications and controls for a nitrosamine drug substance-related impurity. Phathom says it implemented mitigation measures, including a minor drug product tablet reformulation to inhibit the growth of the impurity, and has been conducting a stability program to demonstrate the measures are effective and support the commercial shelf life.

The resubmitted NDA contains three months of stability data for six batches of the reformulated vonoprazan tablets, Phathom says.