CardioExchange Archive

June 27th, 2012

FDA Approves a New Weight Loss Drug, Breaking a 13-Year Drought

Larry Husten, PHD

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 overweight […]

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May 10th, 2012

FDA Advisory Panel Recommends Approval for Weight Loss Drug Lorcaserin

Larry Husten, PHD

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.

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May 8th, 2012

Persistent Concerns About Lorcaserin (Lorqess) from FDA Reviewers

Larry Husten, PHD

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.

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September 22nd, 2011

Diet Drugs Get a New Slim Chance at Approval

Larry Husten, PHD

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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September 16th, 2010

FDA: Dabigatran Gains, Lorcaserin Loses

Larry Husten, PHD

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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