Amgen's Parsabiv Approved With Unusual Postmarketing Requirements
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.
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Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.
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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.