Why isn't agomelatine approved in the US?
Valdoxan
Medications
Status:
Open Oct 08, 2026 - 10:14 AM
1answer
Answer
Oct 08, 2026 - 10:14 AM
Agomelatine is not approved in the US primarily due to concerns about its liver toxicity and questions regarding its overall efficacy compared to existing antidepressants. The FDA found the submitted data insufficient to demonstrate a favorable risk-benefit profile.
View More Product Details
Browse by Category
Medications
View our complete selection of Medications to find the one that suites your needs.
View All
View all Medications Questions & Answers
View all Valdoxan Questions & Answers
