> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Extended Review for Organon’s Vtama sNDA
- URL: https://www.fdaweb.com/extended-review-for-organons-vtama-snda/
- Published: 2024-11-05T12:00:00.000Z
- Updated: 2026-09-14T14:46:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158128

FDA has extended by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream, 1%, for treating atopic dermatitis in adults and children two years of age and older. The revised user fee review action target date is 3/12/2025.

During its review, FDA requested the final datasets and clinical study report from a long-term extension study for Vtama. “After receiving the datasets, the FDA determined that the additional information requested constitutes a major amendment to the sNDA resulting in a standard three-month extension to the original target action date,” the company says. It adds that the agency has not raised any concerns about the Vtama’s safety and efficacy and they have not raised any concerns regarding the approvability of the submission.

Vtama is a non-steroidal once-daily topical treatment currently approved for plaque psoriasis.