Posted from: Monday, August 01, 2016 - 01:24 PM - Present

Belviq XR Approval Issued

July 15, 2016 – The U.S. FDA approved Belviq XR® (lorcaserin) 20mg extended-release tablets, manufactured by Arena and Eisai. Belviq XR is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese adults with a body mass index (BMI) of 30 kg/m2 or greater, or overweight adults with a BMI of 27 kg/m2 or greater who have at least one weight-related comorbid condition such as high blood pressure, type 2 diabetes or high cholesterol. Belviq XR is a Schedule IV controlled substance known as a serotonin 2C receptor agonist. The recommended dose is 20mg once daily. Immediate-release Belviq® is to be taken twice daily and has been on the U.S. market since June 2013. Eisai plans on launching Belviq XR this coming fall.


Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

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Last Updated Wednesday, October 16, 2019 - 06:27 PM.