JERUSALEM—The U.S. Food and Drug Administration has tentatively approved a generic form of Sensipar, according to a May 14 press release from the generic drug’s manufacturer Teva Pharmaceuticals.
The tentative approval for the Teva’s Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg.
Upon final approval, Teva's Cinacalcet HCl Tablets will be the AB-rated generic equivalent of Amgen's Sensipar, indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, according to Teva.
The brand product had annual sales of approximately $458 million in the United States, based on IMS sales data.
Teva said it is currently involved in patent litigation concerning this product in the U.S. District Court for the District of Delaware. A trial date has not been set.
