Amgen Challenge of FDA Decision on Pediatric Exclusivity Could Have Wider Implications
By Zachary Brennan -
Published 08 November 2017
Back in May, the US Food and Drug Administration (FDA) denied a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet), resulting in lawsuit filed by the drugmaker. A JAMA viewpoint published Wednesday argues that a decision in Amgen's favor could end up diminishing FDA's ability to encourage clinically meaningful pediatric studies.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy
Tags: Amgen, Sensipar, pediatric exclusivity, written requests