The FDA announced today that it had approved its first new weight loss drug in 13 years. Lorcaserin, which will be sold under the brand name of Belviq, is manufactured by Arena Pharmaceuticals and will be distributed in the US by Eisai. Lorcaserin is indicated for use in obese adults (BMI 30 or above) or…
FDA Advisory Panel Recommends Approval For Weight Loss Drug Lorcaserin
May 10, 2012 by Leave a Comment
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The result signals a remarkable turnaround for the drug, which the same panel had rejected in September 2010. The vote was 18 in favor of approval, 4 against, and 1 abstention. Committee members seemed less disturbed this time around…
Persistent Concerns About Lorcaserin (Lorqess) From FDA Reviewers
May 8, 2012 by Leave a Comment
The FDA has posted briefing documents for Thursday’s meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reconsider the new drug application for lorcaserin (Lorqess, Arena). The same panel recommended against approval of the drug in September 2010, citing weak efficacy and safety concerns. The FDA reviewers do not appear to have substantially altered…
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