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Home » Regulatory front
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Regulatory front

Feb. 22, 2018
Amgen Inc., of Thousand Oaks, Calif., came up short in its quest to force the FDA to grant it six months of pediatric exclusivity for Sensipar (cinacalcet), which is used to reduce calcium levels. A U.S. district court judge in the District of Columbia tossed Amgen's challenge, granting the FDA's request for summary judgment. The FDA denied the exclusivity, claiming that Amgen didn't "fairly respond" to the written request for pediatric trials because it didn't fully comply with the requirements of the request. For instance, the request required a trial to enroll a minimum of 15 patients ages 28 days to younger than 6 years, but only four patients completed the study.
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