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Pharmaceuticals / Submissions and Approvals

Sensipar Generics Granted Approval by FDA

March 13, 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.

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