Amgen's Parsabiv's Gets EU Approval While It Languishes At The FDA
The EU Commission has approved Amgen’s Mimpara/Sensipar follow-on despite the FDA having blocked its US admission with a complete response letter for the drug.
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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.
FDA issued a complete response letter for the Sensipar follow-on, and Amgen declined to provide any details about the reason why or timeline for resubmission.
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