Why isn't trimebutine FDA approved?
Trimebutine Maleate
Medications
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Open Jun 09, 2026 - 02:08 PM
1answer
Answer
Jun 09, 2026 - 02:08 PM
Trimebutine is not FDA approved primarily because it has not undergone the necessary clinical trials and regulatory review required by the FDA for use in the United States. Additionally, other medications are available for similar indications, and there may be limited commercial interest in pursuing approval.
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