Sensipar Generics Approved
March 8, 2018 – The U.S. FDA has approved AB-rated generics from both Aurobindo and Cipla to Amgen’s Sensipar® (cinacalcet).
Cinacalcet is indicated to treat secondary hyperparathyroidism (HPT) in adult patients who are on dialysis and have chronic kidney disease. It is also indicated to treat high calcium levels (hypercalcemia) in patients with parathyroid carcinoma, or who have primary HPT but are unable to undergo parathyroidectomy.
Aurobindo and Cipla have been granted approval for generic 30mg, 60mg, and 90mg cinacalcet tablets. Launch dates have not yet been announced. IQVIA reports that annual sales for brand name Sensipar total approximately $1.7 billion.
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.