The FDA formally withdrew the drug's approval on September 17, 2020, and subsequently removed it from the Orange Book in 2021, making any sale or distribution into interstate commerce illegal. Clinical Data: The CAMELLIA-TIMI 61 Trial

As a condition of approval, the FDA required the manufacturer, Eisai Inc. , to conduct a long-term trial (CAMELLIA-TIMI 61) to evaluate cardiovascular risks.

Below is a detailed overview of the drug's history, the research leading to its removal, and current safe alternatives. The Rise and Fall of Belviq (Lorcaserin)