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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, 2016Approval Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets
Jun 27, 2012Approval FDA Approves Belviq to Treat Some Overweight or Obese Adults
May 10, 2012Lorcaserin Receives Positive Vote From FDA Advisory Committee
Feb  1, 2012Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin
Jan 10, 2012FDA Accepts Resubmission of Lorcaserin New Drug Application
Jan  4, 2012Arena Submits Response to FDA Complete Response Letter for Lorcaserin
Dec 22, 2010Arena and Eisai Complete End-of-Review Meeting with FDA for Lorcaserin New Drug Application
Oct 25, 2010FDA Issues Complete Response Letter for Lorcaserin New Drug Application
Sep 17, 2010Arena and Eisai Provide Update on Lorcaserin FDA Advisory Committee Meeting
Sep 15, 2010Obesity Expert to Speak to FDA in Support of Treatment Options for Obese Patients
Aug  6, 2010FDA Confirms September 16th Advisory Committee Meeting to Review Lorcaserin for Obesity and Weight Management
Feb 26, 2010Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA
Feb 24, 2010Arena Pharmaceuticals Announces FDA Acceptance of Lorcaserin NDA for Filing
Dec 22, 2009Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.