In a rare development, Amgen filed a lawsuit against the Food and Drug Administration for denying an incentive that drug makers typically receive for studying their medicines for children.
The company argued it was denied an extra six months to exclusively sell its Sensipar drug, which is given to people who are on dialysis due to chronic kidney disease, even after complying with agency requests to run various pediatric studies, according to its lawsuit, which was filed last week in federal court in Washington, D.C.
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…once again confirming the description of Amgen as “a legal company with a pharmaceutical department.”