Following the submission of the New Drug Application (NDA) for PA21, the US Food and Drug Administration (FDA) has announced that it has accepted the filing and assigned a PDUFA (Prescription Drug User Fee Act) target action date of 1 December 2013 to complete its review.
PA21 is a chewable, iron-based phosphate binder for the control of hyperphosphatemia in patients with chronic kidney disease (CKD). Pivotal Phase III data demonstrated that this new phosphate binder successfully controls hyperphosphatemia in patients with CKD with the advantage of a low pill burden.
The European Medicines Agency (EMA) accepted the Marketing Authorisation Application
PA21 is a chewable, iron-based phosphate binder for the control of hyperphosphatemia in patients with chronic kidney disease (CKD). Pivotal Phase III data demonstrated that this new phosphate binder successfully controls hyperphosphatemia in patients with CKD with the advantage of a low pill burden.
The European Medicines Agency (EMA) accepted the Marketing Authorisation Application
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