Amgen suing FDA for Sensipar pediatric exclusivity

In a newly filed lawsuit, Amgen Inc. (NASDAQ:AMGN) is seeking to compel FDA to accept pediatric study reports related to hyperparathyroidism drug Sensipar cinacalcet and extend by six months Amgen's patent exclusivity for the drug.

The complaint, filed in the U.S. District Court for the District of Columbia, requests injunctive relief by June 6 requiring FDA to accept the study reports and recognize the pediatric exclusivity, vacating its decision last week to deny the exclusivity. Amgen said a key Sensipar patent, U.S. Patent No. 6,011,068, is due to expire March 8, 2018...