Belviq FDA Approval History
Last updated by Judith Stewart, BPharm on May 4, 2021.
FDA Approved: Yes (Discontinued) (First approved June 27, 2012)
Brand name: Belviq
Generic name: lorcaserin
Dosage form: Tablets
Company: Arena Pharmaceuticals, Inc.
Treatment for: Weight Loss (Obesity/Overweight)
Belviq (lorcaserin) is a serotonin 2C receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Development timeline for Belviq
|Jul 19, 2016||Approval Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets|
|Jun 27, 2012||Approval FDA Approves Belviq to Treat Some Overweight or Obese Adults|
|May 10, 2012||Lorcaserin Receives Positive Vote From FDA Advisory Committee|
|Feb 1, 2012||Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin|
|Jan 10, 2012||FDA Accepts Resubmission of Lorcaserin New Drug Application|
|Jan 4, 2012||Arena Submits Response to FDA Complete Response Letter for Lorcaserin|
|Dec 22, 2010||Arena and Eisai Complete End-of-Review Meeting with FDA for Lorcaserin New Drug Application|
|Oct 25, 2010||FDA Issues Complete Response Letter for Lorcaserin New Drug Application|
|Sep 17, 2010||Arena and Eisai Provide Update on Lorcaserin FDA Advisory Committee Meeting|
|Sep 15, 2010||Obesity Expert to Speak to FDA in Support of Treatment Options for Obese Patients|
|Aug 6, 2010||FDA Confirms September 16th Advisory Committee Meeting to Review Lorcaserin for Obesity and Weight Management|
|Feb 26, 2010||Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA|
|Feb 24, 2010||Arena Pharmaceuticals Announces FDA Acceptance of Lorcaserin NDA for Filing|
|Dec 22, 2009||Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management|
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