Organon (OGN) said Tuesday that the US Food and Drug Administration has extended its review of the company's supplemental new drug application for VTAMA cream to treat atopic dermatitis in children at least two years old and adults.
The extended review postpones the target action date to March 12, 2025 from the original target action date of Dec. 12, according to the company.
With the new target action date, Organon said it expects about $125 million revenue contribution from VTAMA and an about 75 basis point headwind to adjusted EBITDA margin in 2025.
Organon said the FDA extended the review period after determining that a major amendment to the supplemental new drug application is required based on additional information submitted by the company.
The FDA did not raise any safety and efficacy concerns, Organon added.
Organon shares were 4.5% lower in recent trading.
Price: 16.16, Change: -0.76, Percent Change: -4.49
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