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# Hyloris Pharma NDA Held Up Over Inspection Issues
- URL: https://www.fdaweb.com/hyloris-pharma-nda-held-up-over-inspection-issues/
- Published: 2026-02-19T12:00:00.000Z
- Updated: 2026-09-14T13:34:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160694

Hyloris Pharmaceuticals says a recent FDA inspection of its Greek manufacturing partner resulted in an “Official Action Indicated” designation that could delay approval of its proposed valacyclovir oral suspension product in the U.S. Hyloris says its NDA remains under FDA review, despite a previously assigned review action target date of 10/12/2025.

The company says it has addressed all product-related questions raised during FDA’s scientific review and that, at this time, the agency has not requested additional action from it or its commercial partner. However, Hyloris acknowledged that resolving the manufacturing deficiencies will likely be necessary before the product can secure approval.

According to Hyloris, the manufacturer is actively implementing remediation measures and the facility has temporarily paused production of products intended for the U.S. market.