Generic Approved for Fosrenol
August 16, 2017 – The U.S. FDA has approved Natco Phama’s generic for Shire’s Fosrenol® (lanthanum carbonate). Lanthanum carbonate is indicated for the treatment of patients with end-stage renal disease (ESRD) to reduce high blood phosphate levels (hyperphosphatemia). Recommended dosing is 1,500mg to 3,000mg per day, divided into three doses and taken with food. The generic will be available in 500mg, 750mg, and 1,000mg tablets.
The exclusivity status of Natco’s generic remains unclear, though it is the first generic to Fosrenol to receive FDA approval. Sales of Fosrenol totaled approximately $122 million for the 12 months ending on June 30, 2017, according to Quintiles IMS. Natco will market the generic in partnership with Lupin Pharmaceuticals, and plans to launch the drug closely following its approval.
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.