July 18th, 2012
FDA Approves Another New Weight Loss Drug
Larry Husten, PHD
The US FDA approved on Tuesday a new weight loss drug that will be called Qsymia, the brand name for the combination of two previously approved drugs, phentermine and extended-release topiramate. The drug is manufactured by Vivus, Inc. In a press release, the FDA said Qsymia had been approved for use in obese adults (BMI of 30 or […]
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 […]
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.
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.
October 8th, 2010
Abbott Withdraws Sibutramine from U.S. Market
Larry Husten, PHD
Abbott has pulled its weight-loss drug sibutramine (Meridia) from the U.S. market. A safety communication from the FDA said the “drug may pose unnecessary cardiovascular risks to patients.” Earlier this year the drug was withdrawn in Europe. Sibutramine was approved by the FDA in 1997. The FDA recommendation is based upon a recent analysis of data […]