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…
FDA Advisory Panel Recommends Approval For Weight Loss Drug Lorcaserin
May 10, 2012 by Leave a Comment
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…
FDA Advisory Panel Gives Green Light to Qnexa Diet Pill
February 22, 2012 by 2 Comments
Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this…
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