Pediatric Studies: Must Sponsors Meet Every Detail Of US FDA Request To Get Exclusivity?
In suit against FDA, Amgen argues it provided sufficient data to obtain exclusivity for Sensipar but agency says too few patients were included in one study; court ruled against FDA in similar 2001 dispute.
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However, FDA must explain why denial of Sensipar's pediatric exclusivity was consistent with exclusivity award for J&J's Ortho Tri-Cyclen, US judge says. In swipe at plaintiff Amgen, court says pediatric study reports themselves guide exclusivity determinations, not the amount of effort a sponsor puts into those studies.