Amgen Gets Parsabiv CRL, Gives No Clues As To Why
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.
You may also be interested in...
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.
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.
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.