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
Date | Article |
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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 |
Further information
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