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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.