Generic for Renvela Oral Suspension
June 13, 2017 – The U.S. FDA has approved Aurobindo Pharma Limited’s A-rated generic to Genzyme’s Renvela® (sevelamer carbonate) oral suspension. The drug is indicated to control phosphorous levels in the blood of patients as young as six years old who need dialysis to manage chronic kidney disease. Sevelamer carbonate attaches to phosphorous, which is then eliminated from the body with the drug, which the body cannot absorb.
Aurobindo has begun shipments of the generic, which is available in individual foil packets that each contain either 0.8g or 2.4g of the drug. According to IMS Health, 2016 annual sales for Renvela oral suspension were approximately $137 million.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.