JERUSALEM The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical Industries’ generic version of an Amgen drug, Teva said Friday.
The FDA gave the tentative approval to cincacalcet hydrochloride tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Amgen’s Sensipar, which has annual sales of $458 million, according to IMS Health. The drug is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Tentative approval means that the drug meets most of the conditions for approval, but the FDA cannot grant final approval because the patents covering the drug don’t expire until December 2016, according to FDA records. Teva and Amgen are currently involved in patent litigation concerning the drug in the U.S. District Court for the District of Delaware, though a trial has not been set, Teva said.