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Pediatric Exclusivity: Court Backs US On When Studies 'Fairly Respond' To Requests

 
• By Sue Sutter

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.

Gavel

The US FDA's view that sponsors must provide "clinically meaningful information" to earn six-month pediatric exclusivity is a reasonable interpretation of a statutory requirement that drug sponsors must "fairly respond" to written requests, a federal court ruled in an Amgen Inc. lawsuit related to Sensipar (cinacalcet).

However, FDA must explain why its denial of additional marketing protection for Sensipar was not inconsistent with its pediatric exclusivity...

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