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Amgen's Parsabiv Approved With Unusual Postmarketing Requirements

 
• By Michael Cipriano

US FDA obliges hypothesis-testing observational study to determine whether there is an association with gastrointestinal bleeding and the drug; postmarketing requirements usually seek to determine frequency between a drug and adverse events known to be associated.

Puzzle

In an unusual condition of approval, the US FDA is requiring that Amgen Inc. conduct a hypothesis-testing observational study to determine whether there is an association between its secondary hyperparathyroidism treatment Parsabiv (etelcalcetide) and fatal and non-fatal gastrointestinal bleeding.

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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