First Generic Approved for Renvela Tablets
July 17, 2017 – The U.S. FDA has approved the first generic, manufactured by Aurobindo Pharma Limited, to Genzyme’s Renvela® (sevelamer carbonate) tablets. Sevelamer carbonate 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. Phosphorous is eliminated from the body after attaching to the sevelamer carbonate, which the body does not absorb.
The recommended dosing of Renvela tablets for adults is one or two tablets three times a day. Aurobindo’s generic for Renvela tablets has already been launched. The company had previously launched an A-rated generic to Renvela’s oral suspension formulation in mid-June. Estimated sales of Renvela tablets were approximately $1.9 billion for the 12 months that ended on May 31, 2017.
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.