Amgen has filed a federal lawsuit seeking to reverse FDA’s May 22 decision denying the company six months of pediatric exclusivity for its marketed drug Sensipar® (cinacalcet) for a new indication of secondary hyperparathyroidism (HPT) in children.
The biotech giant is accusing the FDA of violating the Administrative Procedure Act by denying pediatric exclusivity, as well as by depriving the company of its Fifth Amendment right to due process.
Amgen has named FDA Commissioner Scott Gottlieb, M.D., and Thomas Price, M.D., secretary of the U.S. Department of Health and Human Services as defendants in its lawsuit, filed May 25 in U.S. District Court for the District of Columbia.
