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 award for an unrelated product given that studies for both drugs appear to have
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