Judge Puts Amgen’s Exclusivity Lawsuit Against the FDA on Hold

June 7, 2017

A Washington, D.C. federal district judge placed Amgen’s exclusivity lawsuit against the FDA on hold Monday. The case follows the agency’s denial of an additional six months of pediatric marketing exclusivity for Sensipar (cinacalcet), for treating high levels of calcium in the blood of dialysis patients.

Under the order, the FDA will accept Amgen’s resubmission of its exclusivity request as long as the new request is “substantially similar” to the original.

The FDA agreed to make a decision on the resubmitted request by June 26, and to issue a decision on resolving the dispute by Aug. 2. If the agency determines the resubmission meets its requirements, it will update the FDA Orange Book to reflect the exclusivity request.

Amgen brought the suit late last month, claiming the agency denied the drug additional exclusivity despite the company having met the legal requirements. The agency said it denied the request because Amgen failed to complete all the necessary postmarketing clinical trials.

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