www.fdanews.com/articles/185959-sensipar-generics-granted-approval-by-fda
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Sensipar Generics Granted Approval by FDA
March 12, 2018
The FDA granted approval for the first generic versions of Amgen’s Sensipar (cinacalcet hydrochloride), a calcium reducer, to treat a thyroid issue for certain patients on dialysis.
In February, a U.S. District Judge shot down Amgen’s attempt to obtain six more months of market exclusivity from the FDA, a decision which the drug manufacturer stated it would appeal.
Sensipar earned Amgen $1.72 billion in 2017, accounting for 9% of the company’s revenue.