The FDA announced today that it has 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 U.S. by Eisai. Lorcaserin is indicated for use in obese adults (BMI 30 or above), or…

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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The vote was 18 in favor of approval, 4 against, and 1 abstention.

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 reviewers do not appear to have substantially altered their view of lorcaserin.

Contrave, the investigational diet pill combination of naltrexone and bupropion, has been granted a possible new lease on life by the FDA. In January of this year, the FDA issued a complete response letter to Orexigen, the drug’s sponsor. Now Orexigen says that it has received guidance from the FDA that could lead to approval of the…

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An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at…

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