Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older
Organon & Co. (OGN)
Company Research
Source: Business Wire
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024. The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication.As part of its review process, the FDA requested the final datasets and clinical study report from the 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
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