Court sides with FDA in Sensipar exclusivity case

A federal court sided with FDA in a lawsuit in which Amgen Inc. (NASDAQ:AMGN) alleged that the agency had applied standards inconsistently when it denied pediatric exclusivity to Amgen's Sensipar cinacalcet, despite granting the same exclusivity to a drug from the Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ).

The U.S. District Court for the District of Columbia concluded that FDA had provided a reasoned explanation for why it granted pediatric exclusivity to Ortho Tri-Cyclen norgestimate/ethinyl estradiol from J&J, but not Sensipar. The court granted summary judgment to FDA in the case, which Amgen filed in May 2017 seeking to obtain the exclusivity...